Drug Substance Resume Samples

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S Gutmann

Sarina

Gutmann

41316 Wolf Club

Phoenix

+1 (555) 849 6062

41316 Wolf Club

Phoenix

Phone

p +1 (555) 849 6062

Experience Experience

San Francisco, CA

Supervisor, Drug Substance Manufacturing

San Francisco, CA

Gaylord-Boehm

San Francisco, CA

Supervisor, Drug Substance Manufacturing

Help support and establish Hu Management principles on the production floor
Conduct all performance reviews on time. Maintain a score of 100% on-time performance
Develop cross-training plans for productivity objectives and personnel development
Establish and communicate production priorities. Execute production plans and internal goals
Leads and mentors Downstream staff; serves as role-model and provides career direction to develop junior team members
Initiate, encourage, and drive continuous improvement efforts
Track performance and adjust priorities accordingly

Boston, MA

Undergrad Coop-industrial Engineer for Drug Substance AML Department

Boston, MA

Kassulke-Murphy

Boston, MA

Undergrad Coop-industrial Engineer for Drug Substance AML Department

Perform meeting to provide status of assigned projects
Perform process analysis
Perform time studies
Work as a team player and/or independently
Complete Standard Work activities for assigned operations
Support scheduling and green belt capacity model projects
Independently understand, follow and implement basic instructions

present

Phoenix, AZ

Drug Substance Manufacturing Group Lead-downstream

Phoenix, AZ

O'Reilly, Satterfield and Upton

present

Phoenix, AZ

Drug Substance Manufacturing Group Lead-downstream

present

Responsible for the execution of the day-to-day Drug Substance Manufacturing Downstream group operations and may support the establishment of department policies and strategies. Proactively assumes responsibility for downstream tasks
Performs various routine downstream GMP manufacturing tasks under the guidelines of Althea’s established policies and procedures with high focus on attention to detail
Completes all job related, ’read and understood’ and qualified GMP training tasks within Master Control (Quality System Software), trains junior team members, and may develop and implement department training initiatives
Builds sound working relationships with internal departments and external clients in support of company goals
Listens attentively to internal departments and external clients and can relay downstream information, responsibilities and policies respectfully, effectively, and clearly
Fosters the development of junior team members
Commits to working in a team oriented environment in support of the drug substance manufacturing downstream group

Education Education

Bachelor’s Degree in Technical

Illinois State University

Bachelor’s Degree in Technical

Skills Skills

Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary, matrixed environment
Strong laboratory skills and fundamental knowledge of chemical engineering
Ability to work independently or in a team under deadline. Strong verbal and written communication skills are essential
Proficiency in the use of HPLC, GC, Crystal 16 and EasyMax. Experience with process automation platforms, DSC, TGA, and/or XRD are
Ability and drive to learn and implement relevant principles of chemical engineering, material science, analytical chemistry, and regulatory guidelines
B.S. in Chemical Engineering or Related Field
Crystallization development or kilo lab or pilot plant experience is desired

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15 Drug Substance resume templates

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Drug Substance Technical Lead, EU Resume Examples & Samples

Provide technical leadership and support for technical transfer activities, and deviations, investigations, CAPA and change control for global commercial biologic Drug Substance manufacturing
Author/review manufacturing documents and support regulatory submissions, responses and inspections
Identify and manage process improvement activities for existing commercial manufacturing operations
Represent Technical Operations within cross-functional project teams

External Drug Substance Manufacturing Lead Resume Examples & Samples

30% Manage recombinant protein and gene therapy development activities at CMOs
Ph.D. : 10 years
MS: 15 years
BS: 15 years

Drug Substance Technical Integrator Resume Examples & Samples

PhD or MSc in pharmacy, engineering, or equivalent in life sciences
A minimum of 8 years of experience within the pharmaceutical industry in the field of process development, scale up and or manufacturing of biopharmaceuticals
Experience with projects in Phase 3 and beyond is preferred
Willingness to travel 15%

Drug Substance Lead Resume Examples & Samples

We rely on your scientific/technical expertise to develop efficient, high-yield, and robust fermentation processes, supporting successful production of preclinical toxicology material and process transfers to internal and external cGMP manufacturing facilities as well as to provide the required technical documentation for worldwide CTA registration
To meet these deliverables, you adhere to timelines and quality requirements and are responsible for the direct oversight of interfaces
The successful candidate will lead and manage all upstream process development activities for assigned projects within the Biologics Early Phase Development (EPD) Unit, lead and co-ordinate the drug substance team (functional experts) and represent drug substance development on the CMC team
You will be working in multidisciplinary and international teams, reporting scientific/technical results internally (including patents) and representing Novartis externally at meetings, giving talks, part of industry consortiums, publishing papers etc., which results in a wide range of scientific and strategic tasks
The development of new technologies and supervision of scientific projects and external collaborations are further options within this position
Lead and co-ordinate the drug substance team (functional experts) and represent drug substance development on the CMC team. Fulfill all related tasks and responsibilities related to own discipline
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
Design, plan, perform and monitor all assigned drug substance development activities applying state of the art technologies. Meet quality, quantity and timelines in all assigned projects
Interpret results, evaluate data, draw relevant conclusions, and write reports
Generate scientific documents to hand over to internal and external partners (Pilot Plant, cGMP facility, RegCMC, etc.). Actively support generation of international registration documents
Contribute to overall development strategies and improvement of operational excellence of business processes
Contribute to evaluation of new scientific technologies/equipment and proactively identify and realize opportunities for Invention Disclosures
Represent drug substance development in external collaborations and support assigned due diligence activities
Coach junior team members

Scientist Drug Substance Development Resume Examples & Samples

Experience with mammalian cell lines is essential. We are looking for min. 3 years of experience in process development or a related role in an industrial setting
Experience with technical and operational aspects of large-scale equipment is required; experience in late-stage (Phase III clinical and commercial supply) USP or DSP development/characterization/validation, harvest and regulatory filings would be an asset
Further requirements include a team player with strong communication, established presentation and scientific/technical writing skills, good management skills with respect to planning, tracking, priority setting and adherence to project timelines

Global Head Drug Substance Resume Examples & Samples

Responsible for performance of Global Bioproduction Network - Drug Substance according to Balanced Score Card
Develops and implements Bioproduction Network - Drug Substance strategy based on Global BTDM
Effectively allocates resources to meet Bioproduction Network - Drug Substance objectives
Identifies and implements continuous improvement initiatives in line with overall targets
Provides leadership to sites (current Network of 3 drug substance sites in Austria, Slovenia and Switzerland)
Leads Bioproduction Network - Drug Substance Management Team
Develops people talent to sustain both global and local competitiveness
Responsible for global projects and special assignments as defined by Global BTDM Management

Drug Substance Engineering Group Leader Resume Examples & Samples

Introduce and develop new unit operation/equipment to enable safe and efficient scale-up of chemical synthesis
Development of the manufacturing processes and control strategies for drug substance and/or drug product
Preparation of the appropriate manufacturing and controls portion of the IND/CTX and preparation of information for annual updates
Scale-up to manufacturing and support for the preparation of the GMP batches
Preparation or oversight and review of the appropriate manufacturing and controls portion of regulatory submissions
Provides advice and guidance to teams on the development of a commercial development strategy
Writing and timely completion of technical reports and regulatory documents
PhD in engineering or pharmaceutical science or related field with 7+ years of experience OR
B.S. or M.S. in engineering or related field with 15+ years of relevant experience
Knowledge of regulatory guidance on new technology or continuous process commercialization
Experience in leadership role and demonstrated leadership capabilities especially in a team environment
Experience with directing the laboratory activities and development of one or more junior staff members
Demonstrated ability to develop continuous processes in a related industry
Demonstrated ability to apply fundamental understanding of engineering principles into process dynamics
Experience with manufacturing / process support
Ability to prioritize multiple activities and manage ambiguity

Scientist, Drug Substance Development Resume Examples & Samples

Front line member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds
Develop scalable chemical manufacturing processes
Manufacture development candidates for pre-IND studies
Synthesize compounds for use as analytical reference standards
Prepare technical reports, publications, and oral presentations
Excellent laboratory skills and knowledge of organic synthesis. Expertise in the use and interpretation of NMR, MS, IR, HPLC, and GC. Experience with process automation platforms, DSC, TGA, XRD, phototmicroscopy, particle size measurement techniques, and reaction calorimetry are a plus
Proven track record in developing innovative routes and processes for the synthesis of complex molecules

Global Technical Lead for Large Molecule Drug Substance Resume Examples & Samples

Set the strategy of the Global Technology Standard definition and develop, communicate and champion the purpose and value of the Global Technology Standards and engage the engineering community/network in applying the Technology Standards for successful project outcomes and minimized business risk
Establish, maintain and deploy Global Technology Standards and actively monitor the application and performance of Global Technology Standards, identify areas of operational improvements
Establish, maintain and conduct effective training for the Global Technology Standards
Lead the global Community of Practice (COP) for the areas of expertise as well as lead Technology related Key Initiatives
Ensure and provide effective support to sites, affiliates and for Strategic Analysis in area of expertise as required

Drug Substance Resume Examples & Samples

Strong professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
Degree in technical / scientific education, pharma
Advanced degree in technical / scientific education, pharma desired
6 Sigma and Statistical knowledge is an advantage
Broad knowledge and experience within the GMP environment, and regulatory affairs
Successful track record of change management projects and processes
High level of customer orientation and organizational skills
Flexible in mind / out of the box thinking
Enthusiastic, decisive, motivating and convincing personality
International background appreciated
Excellent communication skills, verbal and written communication skills

Drug Substance Working Group Lead-biotech Resume Examples & Samples

Leads a multidisciplinary team (members of e.g. BPDC, Technical Operations, Quality, analytics, and Regulatory) to manage successful Tech Transfer and process qualification (PPQ) at manufacturing scale; including complex investigations
Responsible for pro-active communication and reporting of program (e.g. progress, risks, mitigation) to stakeholders (e.g. functional management and global project teams)
Responsible for alignment between stakeholders regarding program related discussions
Responsible for detailed project plan, estimated FTEs requirements, estimate of CRO costs, raw material costs, including milestones (project metrics) of activities
Participates in strategy meetings to guard end-to-end product focus
Coordination and review of technical reports, CMC modules and responses to questions from authorities
Participates, as subject matter expert, in regulatory inspections and is experienced with the cGMP and regulatory guidelines
PhD in biological sciences, biochemistry, or biochemical engineering highly preferred; Bachelor's Degree required
At least 10 years of relevant experience in managing biotechnological development projects (after PhD)
Experience in people management is a strong plus
Relevant cell culture, purification development and protein chemistry experience preferred
In-depth understanding of the product development trajectory (including cross-functional relationships)
Demonstrated initiative, and innovative process-oriented thinking within a team environment
Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred
Experience in manufacturing sciences preferred
Strong communicator and ability to build bridges between groups and organizations
Excellent oral and written communication skills in English
Flexible attitude of problem solving and conflict avoidance

Bio Drug Substance External Manufacturing Specialist Resume Examples & Samples

Fluent in English, French or German a strong advantage
University degree or equivalent in a Life Sciences Field
Experience of at least 3ys in a large-scale Biotech manufacturing environment
Skilled at writing and reviewing technical documentation, including cGMP documents
Able to actively pursue ideas for improvements, such as manufacturing operational improvements to yields or cost of goods, reduction in project timelines, increasing quality compliance for inspection readiness
Excellent organizational and communication skills as well as demonstrated ability to manage projects and foster relationships within a matrix organization and with external partners

Portfolio Key Account Manager Manufacturing Unit Biologics Drug Substance Resume Examples & Samples

Act as the Single Point of Contact for Risk Management and Project Portfolio Management (business + CAPEX projects) for the Bio DS Manufacturing Unit
Prepare, coordinate and facilitate high-quality Portfolio Reviews at Bio DS LT (incl. business case, project prioritization, portfolio trade-offs, gate reviews, change control, status updates, close-out and benefits realization review, coordination with IT Portfolio Management, risk portfolio and risk mitigation updates) and prepare arguments for decision-making
Provide scenarios for risk mitigations and investments to allow the Bio DS Leadership Team to achieve its goals and monitor the status of projects selected to achieve organizational (strategic) objectives
Communicate process and Bio DS portfolio status and timelines to stakeholders and seek for feedback
Lead the site portfolio and site risk manager communities to execute process across sites and related functions for the annual risk management, and for Project Portfolio Management and CAPEX planning: project intake and prioritization, budget estimation, resource / cost demand-supply verification (incl. Tech Transfer + Technical Product Management projects)

Supervisor, Drug Substance Manufacturing Resume Examples & Samples

Monitor team and individual performance. Maximize productivity, equipment utilization and overall efficiency
Act as the 'go-to' person on shift. Have the answers for all personnel questions on the floor, or retrieve answers quickly for them
Interact very closely with the process and equipment teams to ensure the associates follow proper protocol and ensure product quality
Schedule adequate personnel to support the objectives of the production plan
Maintain leadership presence by spending an overwhelming percentage of time on the shop floor ~80%
Help support and establish Hu Management principles on the production floor
Establish and communicate production priorities. Execute production plans and internal goals
Track performance and adjust priorities accordingly
Initiate, encourage, and drive continuous improvement efforts
Develop cross-training plans for productivity objectives and personnel development
Provide staff with constructive and timely feedback. Enforce company and local policies and procedures
Lead and participate in training as necessary
Maintain positive working relationships with all levels in the organization
Maintain a safe working environment for Biogen employees
Conduct all performance reviews on time. Maintain a score of 100% on-time performance
Excellent interpersonal communications
Data oriented - excels at problem solving and decision making skills
Computer skills - familiar with all Microsoft Office applications (Outlook/Word/Excel/Powerpoint/Access)
Excellent quantitative skills
Ability to handle change quickly and efficiently - Fast paced work environment
Job requires continuous walking across different areas, bending, lifting
Able to lift 50 pounds
Able to sit/stand for 12 hour shifts

Drug Substance Development Chemistry Resume Examples & Samples

Enrolled as a full-time student in an ACS accredited college/university program in chemistry
Undergraduate (Junior/Senior) or Graduate student majoring in chemistry
Available to complete the entire 10 to 12-week internship
Have the right to work in the U.S. without restriction
Minimum 3.2 GPA or higher required
Excellent problem solving, analytical, and interpersonal skills, with an eagerness to learn and desire to make impactful, practical contributions independently, and in a team setting, in a timely manner
Strong organizational, as well as written and verbal communication skills
Technically strong with an overall breadth in general chemistry fundamentals such as a strong basis in organic chemistry, analytical chemistry theory and practice (i.e. NMR, HPLC, GC, IR, UV, etc.) and a desire to learn about laboratory automation. Experience in handling air-sensitive compounds is preferred
Ability to commute to Summit, NJ

Manager, Drug Substance Manufacturing Resume Examples & Samples

Manages and trains Upstream Manufacturing personnel involved in cGMP fermentation, harvest and chromatography load preparation. Ensures that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards
Leads and mentors Upstream staff; serves as role-model and provides career development and direction
Directs and participates in manufacturing activities including scheduling, document production and review, and assures of cGMP compliance. Uses knowledge and skills to train others on execution of manufacturing processes and utilization of equipment
Interacts with clients and interdepartmentally to assure successful technical transfer and integration of processes into Althea’s manufacturing department and to complete manufacturing programs on schedule with well-planned support from all required departments
Functions as subject matter expert for manufacturing programs
Analyzes results, writes and reviews reports, and presents conclusions to internal and external customers
Works with Process Engineering to design related instrumentation and equipment
Employs high level technical expertise to develop new techniques and creatively solve problems, including troubleshooting existing manufacturing processes. Assists other technical personnel to solve issues and problems
Researches and implements new methods and technologies to enhance operations. Suggests improvements to existing methods and procedures
Reviews and approves SOPs, master batch records, and other cGMP documentation
May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group
Leads and/or manages continuous improvement projects pertaining to equipment, processes, systems or training
Manage exempt and non-exempt Biologics Manufacturing staff
Identifies, recruits and retains top-notch talent

Drug Substance Manufacturing Intern Resume Examples & Samples

Acquires knowledge and skills to perform a range of Biologics Upstream and Downstream manufacturing processes under close supervision, including column chromatography, cell culture fermentation, Ultrafiltration/Diafiltration and depth filtration
Maintains up-to-date training on SOPs prior to execution
Collects and disposes of lab wastes according to established procedures

Drug Substance Manufacturing Intern Resume Examples & Samples

With supervision, assists with the development and implementation of training materials and performance improvements for biological manufacturing equipment, processes and quality systems
Assists with the implementation and adoption of operational performance improvements & strategies
Coordinates the scheduling and execution of training sessions for department
Manages records and may assist Sr. Manager with routine duties
Laboratory notebooks, prepare technical reports, summaries, protocols and quantitative analyses
Applies established principles, theories and concepts in area of responsibility, together with a working knowledge of related disciplines
Regular and reliable attendance on a full time basis (or in accordance with posted schedule)

Undergrad Coop-industrial Engineer for Drug Substance AML Department Resume Examples & Samples

Support scheduling and green belt capacity model projects
Perform meeting to provide status of assigned projects
Perform process analysis
Portrait information using Power Point, Excel and Word
Perform time studies
Complete Standard Work activities for assigned operations
Independently understand, follow and implement basic instructions
Prioritize and meet deadlines
Work as a team player and/or independently
Interact constructively with peers
Evaluate documentation and operations according to company procedures
Pursuing a Bachelor’s degree in Industrial Engineering
At least 3.00 GPA (General)
Completed at least 3 years of college education
Not yet graduated
Pursuing an applicable degree or course of study
Be enrolled in school
Computer literacy (Excel Programming, Word, Power Point, Visio and Minitab)
Basic understanding of Good Manufacturing Practice (cGMPs)
Clear and concise writing skills
Strong decision making and efficient time management skills
Basic word processing, presentation and spreadsheet application skills
Good communication skills (both written and verbal in Spanish and English)
Availability to begin between June or July, 2017

Drug Substance Manufacturing Group Lead-downstream Resume Examples & Samples

Responsible for the execution of the day-to-day Drug Substance Manufacturing Downstream group operations and may support the establishment of department policies and strategies. Proactively assumes responsibility for downstream tasks
Performs various routine downstream GMP manufacturing tasks under the guidelines of Althea’s established policies and procedures with high focus on attention to detail
Completes all job related, ’read and understood’ and qualified GMP training tasks within Master Control (Quality System Software), trains junior team members, and may develop and implement department training initiatives
Builds sound working relationships with internal departments and external clients in support of company goals
Listens attentively to internal departments and external clients and can relay downstream information, responsibilities and policies respectfully, effectively, and clearly
Fosters the development of junior team members
Accurately documents data and executes master batch records
Operates downstream production equipment
Assists in resolving downstream equipment or process concerns
May author and/or initiate revisions to current SOPs and/or master batch records or other cGMP documentation (i.e. deviations and preventative actions)
Responsible for routine maintenance of downstream production equipment
Commits to working in a team oriented environment in support of the drug substance manufacturing downstream group
Supports, encourages, and collaborates with others, especially in difficult and high pressure situations

Supervisor, Drug Substance Manufacturing Resume Examples & Samples

Supervises Drug Substance Manufacturing Downstream group projects. Proactively accepts personal responsibility that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards
Leads and mentors Downstream staff; serves as role-model and provides career direction to develop junior team members
Leads the execution of manufacturing campaigns under the guidelines of established SOPs and cGMP regulations
Completes all job related, ’read and understood’ and qualified GMP training tasks within Master Control (Quality System Software)
Builds sound relationships within the Downstream group, clients, and internal Althea departments to assure successful technical transfer and integration of processes into Althea’s Drug Substance Manufacturing department to complete manufacturing programs on schedule with well-planned support from all required departments
Uses knowledge and skills to perform a range of Downstream manufacturing processes, including chromatography, UF/DF and various forms of filtration. Trains junior group members on execution of manufacturing processes and equipment utilization
Functions as subject matter expert with clients for manufacturing programs
Schedules and participates in downstream manufacturing operations for client projects and internal Althea needs
Troubleshoots manufacturing processes. Leads the team to identify issues and proposes adequate solutions
Assists in the research and implementation of new methods and technologies to enhance operations. Participates in the establishment and continuous improvement of downstream policies and procedures
Authors, reviews and approves SOPs, batch records and other cGMP documentation (i.e. deviations and preventative actions)
May cross-train on various tasks including upstream cGMP manufacturing and R&D processes as needed, to support overall success of the Drug Substance Manufacturing group
Maintains cGMP environment in manufacturing suites and remains current in GMP training
Serves as downstream representative during regulatory inspections, internal, and external audits
Supports, encourages and collaborates with others, especially in difficult and high pressure situations
Manage non-exempt Drug Substance Manufacturing Staff
Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating and managing performance and rewarding as appropriate

Research Associate Drug Substance Development Resume Examples & Samples

Core member of a dynamic, scientifically driven team dedicated to the discovery and robust engineering development and scale-up of chemical syntheses and processes for active pharmaceutical compounds
Assist senior researchers in developing scalable chemical manufacturing processes by planning, executing, interpreting, and clearly documenting experiments
Assist with the manufacture of development candidates for pre-IND studies
Support chemical engineering process development experiments, process scale-up, and CRO/CMO support
Responsible for hands on laboratory and kilo lab work
Responsible for supporting crystallization development and experiments
Remain current with required GMP training and qualifications
Assume departmental responsibilities for assigned projects and equipment
Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals
Prepare technical reports and oral presentations
B.S. in Chemical Engineering or Related Field
Strong laboratory skills and fundamental knowledge of chemical engineering
Proficiency in the use of HPLC, GC, Crystal 16 and EasyMax. Experience with process automation platforms, DSC, TGA, and/or XRD are a plus
Ability and drive to learn and implement relevant principles of chemical engineering, material science, analytical chemistry, and regulatory guidelines
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary, matrixed environment
Ability to work independently or in a team under deadline. Strong verbal and written communication skills are essential
Crystallization development or kilo lab or pilot plant experience is desired

Master Coordinator for Biotechnological Drug Substance GMP Production Resume Examples & Samples

Oversee, coordinate and optimize the operator/staff resources in order to support projects and infrastructure/housekeeping needs
Monitor and ensure that plant equipment and infrastructure are properly maintained and kept in efficient operating order while maintaining adequate resource coverage for the ongoing project activities
Generates, in coordination with the Plant Engineer, Biotechnologist and Planning and Scheduling Expert a resource plan for the operating staff to support the planned LSC activities
Negotiates with the Biotechnologist, Plant Engineer and Operating Team Leader a change in the resource plan of the operating staff in order to quickly, efficiently, and professionally respond to sudden requests for additional manpower while maintaining adequate resource coverage for the ongoing project activities
Provide technical expertise in support of operational activities (e.g. support/lead the resolution of process or equipment issues, supports and coaches manufacturing teams, and provides detailed operating instructions when appropriate)
Ensures that the operating staff complies with HSE, cGMP & other requirements, provides adequate training to manufacturing teams, and modifies the training when appropriate
Coordinate and provide guidance to external service providers when appropriate
Identify, lead and execute continuous plant optimization and process improvements initiatives as appropriate

Matrix Team Lead-drug Substance Process Champion Resume Examples & Samples

The Process Champion role is highly cross-functional and challenging, involving technical leadership across all sites of drug substance manufacture for the designated product
The Process Champion helps set strategy for the product franchise by representing drug substance on product strategy teams, and leads a cross-functional technical team that creates and governs the technical project portfolio for the designated product
The Process Champion interacts regularly with site and corporate leadership in assessing resources required, communicating progress and risks, and presenting timelines and strategies for endorsement
The Process Champion represents the drug substance manufacturing process in regulatory interactions such as inspections and other meetings
The Process Champion serves as the primary owner of the drug substance process, and leads or participates in large-scale process validation, regulatory filings, regulatory inspections and responses, technical transfers, troubleshooting teams, change control efforts, process monitoring, continuous improvement, and other technical initiatives
The Process Champion collaborates in efforts involving the site-based MS&T teams to troubleshoot manufacturing issues and develop process improvements using scale-down models of the drug substance manufacturing process
The Process Champion collaborates closely with others in analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy
The position offers the opportunity to provide strong leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
Requires a PhD or MSc in Chemical/Biochemical Engineering or related disciplines with 4+/8+ years of experience in biologics processing
Experience with cGMP regulations, regulatory requirements and CMC authoring for biologics process validation and manufacturing are necessary
Experience in working in/leading cross-functional teams is essential and knowledge of mammalian-based biologics manufacturing processes is preferred
Demonstrated problem solving ability, interpersonal, and oral and written communication skills are essential along with strong leadership skills

Head, Drug Substance Process Development Resume Examples & Samples

Manage all activities for process development of mRNA drug substance
Build and lead a high performing team consisting of scientists and engineers
Interface with internal and external (CMO) non-GMP and GMP manufacturing activities. Identify, manage and contribute to external contracts as required
Be the single point of contact for all Drug Substance process for all partners and ventures in the Moderna ecosystem
Maintain accountability for project success and results delivery
Establish strong bridges with internal groups of formulation development, analytical development, and GMP operations. Interact with other R&D groups (clinical/PK/PD/Tox) to advance the science of RNA vaccines and therapies
Contribute to technical and strategic discussions to advance platforms and product candidates
Communicate development progress and issue resolution
Ph.D. with at least 15 years of industry experience in with at least 10 years biologics (or nucleic acids) purification process development
Strong foundation in biochemical engineering or related discipline. Academic training or subsequent work experience in the area of biophysics/biochemistry, biomolecular interactions, colloidal science, and related areas
A track record of achievement in product development, supporting clinical/commercial programs in biotech/pharma. Filing of INDs and BLAs
Proven ability to define, manage and maintain scientific business relationships and contract research / manufacturing agreements
People management and organization development
Experience with nucleic acid or polysaccharide process development
Experience defining and executing development based on QbD principles

Scientist, Drug Substance, Antigen Expression Resume Examples & Samples

BSc Degree in virology, molecular biology, cell biology or other vaccinology related discipline
At least 5 years of experience in research and development, preferably including vaccines research in an industrial, academic or government laboratory setting
Hands-on and in-depth understanding of different protein expression platforms, cell transfection and selection in transient and stable expression systems
MSc OR PhD degree in virology, molecular biology, cell biology or other vaccinology related discipline
Excellent communication skills, ability to effectively interface with multiple project work streams
Ability to efficiently manage uncertainty, changes in priority and timeline restrictions
Hands-on cell clone isolation and single cell cloning; using FACS analysis and sorting would be desirable
Experience with molecular biology methods; plasmid and viral vector design and optimization
Next Generation Sequencing
Solves complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment. Fully understands the rationale and hypotheses for experimental designs
Works with minimal supervision in a matrix environment and effectively manages multiple project activities
Executes and documents experiments/technical studies/tasks independently, maintaining good scientific practices
Interprets results and communicates to his/her supervisor and/or designs next logical step of experiments based on the data analysis
Participates in project and technology transfer efforts
Designs and executes new methods and protocols related to area of expertise
Prepares detailed oral or written summaries of results with interpretation for projects/programs. Independently writes specific technical sections of internal and external reports
Understands regulatory requirements that apply to vaccine development; interacts with health authorities to ensure successful registration vaccine candidates