... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
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... bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays. Essential ...
D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of ...
D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of ...
D. in analytical chemistry or bioanalytical chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15 ...
D. in analytical chemistry or bioanalytical chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15 ...
D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of ...
D. in Analytical Chemistry or Bioanalytical Chemistry, with 5+ years of experience in the pharmaceutical industry after earning degree; or alternatively a B.S. in Chemistry with 15+ years of ...
D. in analytical chemistry or bioanalytical chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15 ...
D. in analytical chemistry or bioanalytical chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15 ...
Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with 7+ years of experience in the biopharmaceutical sector following graduation * 2+ years of experience in people ...
Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with 7+ years of experience in the biopharmaceutical sector following graduation * 2+ years of experience in people ...
Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with 7+ years of experience in the biopharmaceutical sector following graduation * 2+ years of experience in people ...
Ph.D. in analytical chemistry, bioanalytical chemistry, or a related field with 7+ years of experience in the biopharmaceutical sector following graduation * 2+ years of experience in people ...
Bioanalysis Director information
What are the key skills and qualifications needed to thrive as a Bioanalysis Director, and why are they important?
A Bioanalysis Director should possess an advanced degree in life sciences, extensive experience in bioanalytical method development, and a strong understanding of regulatory guidelines such as GLP and GCP. Familiarity with analytical instruments like LC-MS/MS, LIMS, and relevant certifications (e.g., ASCP or equivalent) are commonly required. Strong leadership, project management, and communication skills are essential for coordinating teams and collaborating with stakeholders. These competencies ensure scientific rigor, regulatory compliance, and efficient delivery of high-quality data in bioanalytical studies.
What are some common challenges faced by a Bioanalysis Director when leading cross-functional teams in pharmaceutical research?
A Bioanalysis Director often encounters challenges related to coordinating efforts across multidisciplinary teams, such as scientists, project managers, and regulatory specialists. Ensuring clear communication, alignment on project timelines, and compliance with regulatory standards can be complex, especially in fast-paced environments. Additionally, balancing resource allocation and adapting to shifting scientific priorities requires strong leadership and strategic planning. Overcoming these challenges is key to delivering high-quality analytical data that supports drug development milestones.
What does a Bioanalysis Director do?
A Bioanalysis Director oversees the design, implementation, and management of bioanalytical studies, typically within pharmaceutical or biotechnology organizations. They ensure that laboratory operations comply with regulatory standards and that analytical methods for measuring drugs, metabolites, or biomarkers are validated and reliable. Responsibilities also include managing scientific teams, coordinating with other departments, and representing bioanalytical interests in project meetings. Ultimately, they play a key role in ensuring the integrity and quality of data used in drug development.
What is the difference between Bioanalysis Director vs Bioanalytical Scientist?
| Aspect | Bioanalysis Director | Bioanalytical Scientist |
|---|---|---|
| Required credentials | Advanced degree (PhD or MS), leadership experience | Bachelor's or Master's in life sciences, specialized training |
| Work environment | Management, strategic planning, overseeing teams | Laboratory research, method development, data analysis |
| Employer usage | Pharmaceutical, biotech companies, CROs | Research labs, biotech firms, CROs |
| Search intent | Leadership roles, management, strategic oversight | Technical skills, laboratory work, data generation |
The Bioanalysis Director typically oversees the entire bioanalytical department, focusing on strategy and management, while the Bioanalytical Scientist conducts hands-on laboratory research and method development. Both roles are essential in the bioanalysis field but differ in responsibilities and seniority.
What are popular job titles related to Bioanalysis Director jobs in Indiana? For Bioanalysis Director jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Bioanalysis Director jobs in Indiana look for? The top searched job categories for Bioanalysis Director jobs in Indiana are:
Job description
JOB SUMMARY
Responsible for driving all aspects of the Analytical and Microbiological Quality Control (QC) laboratories at Genezen. This individual provides leadership, scientific and technical expertise for all QC activities, as well as support to Analytical Development for all method qualification/validation activities. This person is also the facility aseptic subject matter expert, including responsibilities for the environmental monitoring program. The ideal candidate must have in-depth knowledge and experience in a cGMP/ GLP testing lab.
ESSENTIAL JOB FUNCTIONS
- Ensure timely in-process and release testing of early clinical grade biopharmaceuticals
- Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, and cell-based assays)
- Monitor, maintain and continuously improve the environmental monitoring program, including conducting Environmental Monitoring Performance Qualifications as needed
- Develop, implement and maintain EM trending program and metrics, including Annual Reports and evaluation of alert levels
- Develop, implement and maintain an in-house isolates program
- Responsible for Disinfectant Efficacy Program
- Responsible for the Analytical laboratory equipment systems and software (e.g., ddPCR, Flow, etc.) including purchase, calibration, IOPQ activities, etc. to meet the compliance (data integrity) requirements and project timelines.
- Support the Analytical Development team in qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
- Support the tech transfer of bioassays from clients to cGMP QC testing lab
- Represent QC Analytical and Microbiological in client meetings and programs
- Establish and maintain the stability program
- Oversee LIMS development, implementation, operation, troubleshooting and maintenance
- Responsible for all laboratory logistics activities including, but not limited to sample management, test/release schedule, cycle time matrix, capacity management, etc.
- Manage outside contract laboratory relationships, including method qualification/validations, investigations, audits, cost and invoices to meet project timelines and business requirements
- Support OOSs/OOTs and other lab investigations, deviations, CAPAs, change controls, audits, and training
- Analyze regulatory authorities' programs, guidance documents, and activities in areas relevant to testing of cell and gene products
- Develop, implement and present metrics for monitoring of lab operations and stability program
- Participation in client audits and regulatory inspections as SME and development of responses to observations
- Responsible for hiring and development of team members, conduct performance review and disciplinary actions.
- Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area
KNOWLEDGE, SKILLS, AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
BS in a scientific/technical discipline
Essential
MS in a scientific/technical discipline
Preferred
ON-THE-JOB EXPERIENCE
7+ years of experience in a QC leadership position within the biological industry
Essential
Proven technical leadership and experience in bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays.
Essential
Familiarity with viral vector release assays
Preferred
Proven lab operations management experience
Preferred
3+ years of cGXP experience
Preferred
SKILLS / ABILITIES
Ability to maintain multiple projects and timelines
Essential
Strong people leadership skills
Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
- Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
- Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
- Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
- Occasionally exposed to extremely loud noise levels
- Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required
Movement
- Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Occasionally lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
About Genezen Laboratories
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Indianapolis, IN, US
Year founded
2014