Drug Substance Job Description

Drug Substance Job Description

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Drug substance provides QA oversights on all activities related to the establishment and transfer of manufacturing processes into the new biotechnological production.

Drug Substance Duties & Responsibilities

To write an effective drug substance job description, begin by listing detailed duties, responsibilities and expectations. We have included drug substance job description templates that you can modify and use.

Sample responsibilities for this position include:

Design, plan, supervise and monitor all activities of assigned units/projects
Lead, manage and support the technical drug substance sub-team with regard to late stage development processes through clinical and commercial drug substance (DS) supply (incl
Ensure demand and supply alignment through Supply Chain Planning
Ensure that inventory is kept at target level and highlight discrepancies and risks
Lead continuous improvement projects to drive expanded capabilities and improve the efficiency of existing processes
Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations
Performs independent technical review of documentation during and post-execution of cGMP activities
Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery, development, and optimization of safe, scalable, and efficient chemical syntheses and processes for active pharmaceutical compounds
Lead and manage day-to-day operations of the Drug Substance Development kilo-lab facility, with responsibility for GMP and non-GMP processing activities
Lead the global Community of Practice (COP) for the areas of expertise lead Technology related Key Initiatives

Drug Substance Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Drug Substance

List any licenses or certifications required by the position: CPI, CPR, APICS

Education for Drug Substance

Typically a job would require a certain level of education.

Employers hiring for the drug substance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Manufacturing, Chemistry, Science, Chemical Engineering, Life Sciences, Biotechnology, Biochemistry, Technical, Sciences

Skills for Drug Substance

Desired skills for drug substance include:

Organic synthesis
Pharmaceutical/biotech processes
Biotechnological manufacturing processes in cGMP
ChemDraw
Excel
PowerPoint
SciFinder
ASTM 2500
Principles and concepts of a discipline
Biologics industry with a focus on:

Desired experience for drug substance includes:

Occasional domestic or international travel will be requiredR&D
Experience with mammalian cell lines is essential
Experience with technical and operational aspects of large-scale equipment is required
Requires a Bachelor’s degree, from an accredited institution, in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation)
Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas or equivalent
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects

Drug Substance Examples

1

Drug Substance Job Description

Job Description Example
Our growing company is looking to fill the role of drug substance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug substance
  • Lead the Global Biologics MSAT-DS team and report directly to the head of Global Biologics MSAT and Global Packaging Development (gPKD)
  • Chair Drug Substance Technology Council (DSTC) which is accountable for MSAT support throughout the network
  • Provide scientific and technical input to facilitate decision making for DS manufacturing network and commercial product management
  • Accountable for development and governance of harmonized business processes and tools related to DS for manufacturing support, tech transfer and manufacturing innovation management
  • Support the execution of DS Manufacturing Network Optimization, which includes technology transfers to enable the close-down and start-up of DS plants
  • Provide the technical leadership to support all the activities related to DS commercial CMO and partner manufacturing activities
  • Serve as Quality Assurance SME for Drug Substance Manufacturing Processes maintaining knowledge of industry standards and regulatory requirements to ensure all product manufacturing, storage and shipping activities are compliant
  • Providing oversight of GMP systems completed by CMOs and External Supply Chain function related to Drug Substance
  • Support contract manufacturing organisation audits, including regulatory authority inspections and audit responses as necessary
  • Develop and issue quality metrics pertaining to quality activities
Qualifications for drug substance
  • Visual Demands - Must be able to read and see clearly
  • Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions
  • BS or higher degree in Chemistry, Chemical Engineering, or closely related discipline, or relevant experience in lieu of degree
  • Minimum of 8 years experience in the pharmaceutical industry in small molecule drug substance development and facility operations
  • Understanding and application of cGMPs and current regulatory standards in drug substance manufacturing for global clinical programs
  • Experience in pharmaceutical development as it relates to drug substance process development, GMP/non-GMP manufacturing, scale-up, technology transfer and process safety
2

Drug Substance Job Description

Job Description Example
Our growing company is looking to fill the role of drug substance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for drug substance
  • Represents Quality Assurance to guide various projects, process or procedure updates and technical meetings, as needed
  • Responsible for review of executed DS batch records and CMO disposition pack and performance of SAP usage decisions for batch
  • Responsible for training and mentoring other team members
  • Responsible for review and approval of internal protocols, reports and regulatory filing updates as required
  • Lead quality meetings with CMOs and represent QA on all other team meetings with CMOs
  • Act as delegate for QA Drug Substance Manager as required
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables
  • Initiate and complete routine technical tasks
  • Prompt and regular attendance to workplace
Qualifications for drug substance
  • Demonstrated ability to balance technical needs, resource requirements, and other business considerations across multiple assigned projects
  • Experience with broad CMC issues encountered in drug development, and experience with regulatory filings (IND/NDA) are highly desirable
  • Experience in operations involving highly potent compounds a plus
  • Experience with directing the laboratory activities and development of junior staff members
  • Ph.D., M.S
  • Minimum of 10-12 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry
3

Drug Substance Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of drug substance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug substance
  • Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications
  • Serve as final decision –maker and spokesperson for the Quality Unit
  • Define the strategies needed to reach the site and network goals
  • Provide technical direction and leadership to support routine audits regularly visit manufacturing floor and QC laboratories
  • Lead Health Authority inspections and Third Party audits at the site and support other sites during inspections and resolution of network issues/risks s required
  • Work with internal business partners to proactively identify, communicate, resource and manage Quality and Compliance Risks in a timely manner
  • Be a excellent network partner through sharing of best practices and lesson learned
  • Build meaningful partnerships with the site leadership team to assure alignment around strategic priorities and day to day priorities
  • Approval of contracts with quality relevant content
  • Solves complex problems through analytical thinking
Qualifications for drug substance
  • Educational background in Mechanical, Electrical and/or Chemical Engineer
  • Familiarity with validation processes and documentation in a highly regulated environment
  • Hands-on experience with culturing cells, operating microbial fermenters and/or mammalian bioreactors harvesting material using centrifugation, depth filtration and/or TFF
  • Hands-on experience with purification techniques including operation of AKTA and UF/DF systems analytical methodologies (SDS-PAGE, HPLC, spectrophotometry)
  • Working knowledge of CMC regulatory requirements for biological pharmaceutical products at various stages of development practical application of principles of QbD
  • Leads a multidisciplinary team (members of BPDC, Technical Operations, Quality, analytics, and Regulatory) to manage successful Tech Transfer and process qualification (PPQ) at manufacturing scale
4

Drug Substance Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of drug substance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug substance
  • Engage on impactful technical projects to enhance manufacturing commitment with external parties
  • Monitor team and individual performance
  • Act as the 'go-to' person on shift
  • Provide staff with constructive and timely feedback
  • EBR (Electronic Bath Record) System Configuration
  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints
  • Work with consultants, architects and engineering firms on development of standard design documents
  • Obtain and critique quotes for equipment modifications or installations
  • Generate rudimentary project cost estimates and schedules
  • Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments
Qualifications for drug substance
  • Responsible for pro-active communication and reporting of program
  • PhD in biological sciences, biochemistry, or biochemical engineering highly preferred
  • At least 5 years of experience in industrial bioprocess development or manufacturing including experience working in a global matrix organization
  • At least 5 years of experience in research and development, preferably including vaccine research in an industrial, academic or government laboratory settings
  • Hands-on cell clone isolation and single cell cloning, FACS analysis and sorting
  • Experience with viral vectors and virology background would be an advantage
5

Drug Substance Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of drug substance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for drug substance
  • Gain an understanding of how to develop scalable isolation processes for intermediates and active pharmaceutical ingredients
  • Learn to utilize analytical techniques such as HPLC, UPLC, and UPLC-MS to evaluate reaction performance and identify impurities
  • Apply laboratory automation techniques toward expediently solving fundamental chemistry problems
  • Preparation of a summer-end presentation and report
  • Manages and trains Upstream Manufacturing personnel involved in cGMP fermentation, harvest and chromatography load preparation
  • Leads and mentors Upstream staff
  • Directs and participates in manufacturing activities including scheduling, document production and review, and assures of cGMP compliance
  • Oversee Upstream and Downstream MS&T laboratories to support biological drug substance processes at Devens, Massachusetts and contract manufacturing organizations
  • Oversee Manufacturing Technology functions supporting commercial manufacturing at Devens site
  • In collaboration with Biologics Process Development, responsible for large-scale technical-transfer activities for late-stage clinical and commercial manufacturing processes, including establishment and support of process control strategies, specification windows, and comparability packages that lead to successful validation and commercialization
Qualifications for drug substance
  • Excellent organizational and communication skills demonstrated ability to manage projects and foster relationships within a matrix organization and with external partners
  • Extensive DS development experience in biopharmaceutical or biotech industry
  • Have knowledge in regulatory guidelines and regulatory document preparation
  • The candidate must be well organized and have excellent oral and written communication skills, and be able to communicate and connect with all levels of the organization
  • Demonstrated ability to function in a collaborative/team oriented environment
  • Prepare, coordinate and facilitate high-quality Portfolio Reviews at Bio DS LT (incl

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