Scientist, Biologics Job Description
Scientist, biologics
provides technical expertise in the operation of the continuous manufacturing rig and support delivery of drug product manufacturing campaigns in a cGMP environment.
Scientist, Biologics Duties & Responsibilities
To write an effective scientist, biologics job description, begin by listing detailed duties, responsibilities and expectations. We have included scientist, biologics job description templates that you can modify and use.
Sample responsibilities for this position include:
Act as a DP tech transfer lead, interfacing with R&D and internal sites or Contract Manufacturing Organizations (CMO’s) for new product development teams
FTIR, NIR, Particle size testing
You will be the technical and Group Leader responsible for representing Formulation and Delivery Team consisting of Ph.D
You will work closely with protein engineering scientists, peptide chemists, ADME scientists, and biologists to characterize and understand how biophysical and formulation properties of novel biotherapeutic peptides, proteins, and antibodies relate to the overall profile of a clinical candidate molecule
You will have broad understanding of discovery, development, and manufacturing issues associated with biotherapeutic formulation and delivery and will be expected to work across all levels of the organization to drive results on individual projects broader strategic objectives
Candidate will develop, optimize, validate and troubleshoot analytical methods to support therapeutic protein development
Maintains familiarity with scientific literature and applies appropriately to projects
Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors
Lead a group of scientists and research associates for assay development and method validation to support noclinical and clinical PK/PD
Interact with the functional teams within the department and groups outside to represent GBT PK/PD bioanalytics functional area
Scientist, Biologics Qualifications
Qualifications for a job description may include education, certification, and experience.
Education for Scientist, Biologics
Typically a job would require a certain level of education.
Employers hiring for the scientist, biologics job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Biology, Biochemistry, Performance, Physical Science, Life Sciences, Education, Chemical Engineering, Biological Sciences, Engineering
Skills for Scientist, Biologics
Desired skills for scientist, biologics include:
CGMPs
Requirements of working in a GLP
Current Good Manufacturing Practices
CGMP environments
Downstream unit operations
Analytical method development
CGMP
Current US
EU
Global Regulations
Desired experience for scientist, biologics includes:
Hands-on technical leadership of all aspects of protein characterization and lot release
The candidate will oversee or execute the R&D stability testing of final dosage forms, characterize degradation pathways and products, conduct compatibility studies with drug-delivery devices (pre-filled syringes, auto-injecting systems, ) and other container closure systems
May lead the Drug Product technology transfer from process development to clinical and commercial manufacturing sites, serve as the technical representative during fill/finish operations and participate in technical troubleshooting
Experience conduction drug product manufacturing risk assessments to identify critical process parameters (CPPs), designing and executing process characterization studies to define CPP targets and ranges for manufacturing unit operations as part of a Quality by Design approach to process development
Experience with Regulatory Filings including authoring relevant sections of INDs/CTDs, response questions, is desired
The applicant should be an effective communicator of ideas and results to team members within cross-functional roles/departments
Scientist, Biologics Examples
1
Scientist, Biologics Job Description
Job Description Example
Our company is growing rapidly and is looking for a scientist, biologics. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, biologics
- Write regulatory submission document including method validation reports, bioanalytical reports and correspondence documents
- Collaborate with other functional areas from early discovery to clinical development in order to achieve biomarker goals
- Provide technical expertise for evaluation and selection of Biomarker approaches and assay format
- Design, optimize and perform fit-for-purpose method validation and test specimens
- Interpret and report results
- Selects functional antibodies using phage display technology
- Utilizes automated technologies for processing samples (QPix, TECAN, iQue)
- Prepares DNA sequencing and analyzes sequence results
- Constructs expression vectors for protein expression
- Expresses, purifies and characterizes antibodies in biochemical and/or functional assays
Qualifications for scientist, biologics
- Minimum of 5 years of relevant experience in biologics or vaccines method development, plus validation
- Bachelor's degree in B io-Engineering, bio-related Science or related-field with a minimum of 7 years of relevant experience in biologics or vaccines method development, plus validation
- Lead design and execution of method transfers to national and global network of biologics and vaccines nodes
- Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture
- Undertake purification process development experiments for fundamental understanding of individual unit operations
- Assist with the evaluation of new bioprocess technologies
2
Scientist, Biologics Job Description
Job Description Example
Our company is searching for experienced candidates for the position of scientist, biologics. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, biologics
- Records and captures all necessary data for internal use and IND filings
- Develop LC-MS and hybrid LBA/LC-MS methods for the bioanalysis of biopharmaceuticals, biomarkers and immunogenicity
- Carry out projects with minimal coaching and use sound judgment in prioritization
- Design and execute assay qualification and validation, prepare validation protocol, method validation report, and standard operating procedures
- Evaluate and implement new technologies to expand capabilities and enhance efficiencies
- Conceive and execute experimental strategies in the field of oncology, immunology and immuno-oncology to support biologic drug discovery with current focus on T cell-based therapy
- Evaluate novel pathways and mechanisms for immunological therapeutic modulation
- Establish and apply in vitro and ex vivo assays at bench, and collaborate with various groups to design, characterize and identify novel biologic therapeutics for PK, in vitro and in vivo efficacy/safety, drugability, and manufacturability
- Self-motivated, excellent communication and interpersonal skills to work productively as part of a highly collaborative interdisciplinary team
- Able to develop efficiently and deliver scientific presentations, reports and publications
Qualifications for scientist, biologics
- Comfort with handling live animals strongly preferred
- Candidates must not be allergic to small animals/rodents (rabbit, guinea pigs, hamsters, mice, rats)
- Prior experience in a lab as a Lab Tech is preferred
- Good MS Office Suite experience and experience with LIMS is desired
- A PhD or Pharm D in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences OR a PhD or Pharm D completed by Mach 2017 in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences OR a MS in Pharmaceutical Sciences, Clinical Pharmacology, or Biological Sciences with at least 5 years of experience is required
- Experience in biologics and/or small molecules drug development is preferred
3
Scientist, Biologics Job Description
Job Description Example
Our company is looking for a scientist, biologics. 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 scientist, biologics
- Investigate predictive surrogate assays of protein stability and behavior
- Design and execute assays for high throughput drug-like property assessment of biopharmaceuticals
- Demonstrate scientific excellence, work ethic, and dedication to project goals
- Work collaboratively in a highly matrixed environment, and add value through scientific insight
- Contribute to the development and characterization of drug product processes for internal projects and/or in collaboration with external partners (CMOs, CROs)
- Execute the experimental work according to planning, timely meeting the project goals
- Maintain and calibrate the assigned equipment in use
- Communicate and follow-up on activities progress and outcome to internal/external stakeholders
- Assist in scale up and tech transfer to the GMP facilities
- Keep track records of achievements outcomes
Qualifications for scientist, biologics
- Extensive experience with LCMS-based assay development and validation/qualification
- Excellent working knowledge of HPLC, triple quad MS, extraction techniques and quantitative assays by LC-MS/MS
- Extensive experience in bioanalysis in GLP compliance environment
- PhD in immunology or related field, preferably with 0-5 years of postdoctoral experience
- Have in-depth knowledge in immunology, especially molecular and cellular biology of T cells, and good understanding of drug discovery
- Proficiency in a wide range of immunological, cell biology and biochemistry techniques, such as human leukocyte and tissue preparation, tissue culture, in vitro and ex vivo bioassays, flow cytometry, immunofluorescence, receptor occupancy assay, and pharmacological assays is required
4
Scientist, Biologics Job Description
Job Description Example
Our growing company is looking to fill the role of scientist, biologics. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for scientist, biologics
- Vironment
- Effective in communication and strongly results oriented
- Independent planning of experiments and ‘hands-on’ work in the lab for the development of cell-based potency assays, ELISA and other binding assays within NBE Analytical R&D
- Data review and interpretation, documentation and preparation of reports and Powerpoint presentations
- Elaborate new analytical methods and extend the existing method repertoire
- Functioning independently as the Principal Investigator and technical expert, on highly complex studies, develop, perform, and troubleshoot experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics, by mass spectrometry, particularly HPLC-MS
- Develop and optimize cell-based, immunochemical and chromatography-based analytical methods (in lab)
- Have a first-hand opportunity to evaluate her or his potential for future employment
- Work closely with biologics development scientists to learn about pharmaceutical drug development, immunogenicity and the Anti-Drug Antibody (ADA) assay development process
- Contribute to the development and broadened utility of novel automation platforms
Qualifications for scientist, biologics
- Prior experience with functional antibody/biologics characterization such as BIAcore, ELISA and FACS assays and mechanism of action studies is a plus
- Bachelor’s Degree or equivalent education and typically 7 years of experience or Master’s Degree or equivalent education and typically 5 years of experience
- Experience in the analysis of large data sets
- Expertise in protein analytical techniques for the assessment of drug like properties of biopharmaceutical candidates such as UHPLC, MS, DSC, DLS
- Experience with basic protein assays such as ELISA, FACS, and BLI/SPR
- Proven track record of developing efficacy assays of monoclonal antibodies and other form biologics candidates using all or any of the following BIAcore, Octet, HTRF, AlphaScreen, ELISA, MSD
5
Scientist, Biologics Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of scientist, biologics. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for scientist, biologics
- Work on a valuable project exploring, building and developing Big Data analytic models using tools such as multiple regression and decision trees for optimizing assay development
- Other activities may include exploring alternative software tools, providing insights to data analytics applications in other areas of biologics development and healthcare, presenting work on new and innovative development methods at cross-functional department meetings
- Develop formulation selection strategies and lead execution of formulation studies for biopharmaceuticals including supporting those studies as required analytically via physical, biochemical and characterization analysis such as MFI, viscosity, UV-Vis spectroscopy, HPLC, DLS and CD
- Represent DPDO in cross functional matrix teams as it relates to biosimilar and novel biologic products
- Maintain a laboratory notebook including writing up experiments, data analysis and review
- Support activities across DPDO including supporting fill/finish, life cycle management and platform development activities
- Support cross department activities with analytical, upstream and downstream groups as required
- Mentor and supervise junior scientist in the department
- Executes protein binding assays such as ELISA or FACS in a high-throughput format
- Constructs libraries for affinity maturation of clones
Qualifications for scientist, biologics
- In-depth knowledge and experience in sample preparation techniques of proteins/peptides is desired
- Experience with automation of sample preparation and analyses quantitative mass spectrometry is highly desirable
- Polymerase Chain Reaction (PCR) based analytical testing for new and in-line vaccine programs in support of Value Chain Management Team objectives encompassing Cost of Goods (COGS) reduction, cold chain footprint reduction, and tactical process manufacturing and analytical capacity increases
- Stakeholder collaboration including study design and project timeline development
- Analytical testing support, troubleshooting, and optimization of analytical methods for in-line products
- System administration for control of laboratory testing, laboratory data, material inventories, forecasting, and metrics