Quality Control Manager
Genezen Laboratories Fishers, IN
- Expired: over a month ago. Applications are no longer accepted.
JOB TITLE: Quality Control Manager
REPORTS TO: Chief Scientific Officer
DEPARTMENT: Quality Control
JOB CLASSIFICATION: Professional
STATUS: Full-Time Salaried
- Genezen Laboratories is actively seeking a Quality Control (QC) lab manager to join a Lentiviral vector manufacturing CDMO located in Fishers, IN. The QC Manager will drive all aspects of the QC lab at Genezen. This individual is expected to have strong, hands-on, technical experience of gene therapy cell-based assays as well as characterization assays for viral vectors. This individual provides leadership, scientific and technical expertise for all QC activities. The person in this role is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and lead the execution of complex experiments.
ESSENTIAL JOB FUNCTIONS:
- Maintain multiple projects and timelines. Timely in-process and release testing of early clinical grade biopharmaceuticals.
- Manage the QC team, including hiring, training, career and goal development and assessment.
- 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, sterility and endotoxin assay, and cell-based assays.
- Maintain familiarity with current equipment used in quality control lab.
- Perform qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors.
- Tech transfer of bioassays from analytical development or clients to cGMP QC testing lab.
- Directly supervise multiple QC associates and techs.
- Work closely with other departments, assisting in project planning.
- Facilitate and participate in viral vector contract development.
- Serve in regulatory inspections and client audits.
- Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients.
- Establish and maintain stability programs for clients.
- Support and lead establishment of electronic LIMS systems for site.
- Analyze regulatory authorities’ programs, guidance documents and activities in areas relevant to testing of biological products.
- Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Execute research timelines to meet program and corporate objectives.
- Evaluate the functional strengths and developmental areas in the QC organization and focus on continuous improvement.
- Provide monthly reports to department head.
KNOWLEDGE, SKILLS AND EXPERIENCE:
- BS in a scientific/technical discipline required.
- 3-5 years of experience in a QC leadership position within the biological industry.
- 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.
- Strong people leadership skills.
- Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs.
- Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential.
- MS in a scientific/technical discipline.
- Familiarity with viral vector release assays.
- Proven lab operations management experience.
- 3+ years of cGXP experience.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to work in a BSL 2/3 environment with personal protective equipment.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
- Paid vacation days, amount based on tenure, and paid sick time
- 8 observed holidays + 1 floating holiday
- 401(k) plan with company match up to 6% of salary, vested immediately
- Choice of five healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
Genezen LaboratoriesWhy Work Here?
Genezen Laboratories is located in Fishers, Indiana, a suburb of Indianapolis.
Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500 and the world’s largest children’s museum to name just a few reasons why this area is a great place to live.
ManufacturingView all jobs at Genezen Laboratories