Quality Control Method Transfer Manager
INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Control Method Transfer Manager. They are seeking a highly motivated individual and detail-oriented who will lead a team of scientists who will be dedicated to producing the highest quality products for our clients.
This position reports directly to the Director, Quality Control and is a member of INCOG’s Quality Control Leadership Team. The QC Method Transfer Manager plays a vital role on the INCOG team, and will have a passion for learning, collaborating, and contributing to the success of INCOG’s clients. The QC Method Transfer Manager will be dedicated to the success of the QC Method Transfer team, resulting in the production of the highest quality products for INCOG’s clients.
The successful individual will work closely with QC leadership and QC Method Transfer Scientists to lead the program for performing method transfer for analytical and/or microbiological assays from client laboratories into the INCOG QC laboratories. The QC Method Transfer Manager will be committed to operating with a quality mindset in every aspect of their role, including attention to detail, on time delivery and efficiency.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.
Job Functions:
- Lead the enhancement of the INCOG QC Method Transfer program for both analytical and microbiological assays.
- Perform assessments of both incoming client methods and compendial test methods for raw materials, container/closures, API/BDS, in-process, and finished products for suitability with existing INCOG laboratory capabilities by reviewing client proposals and project plans.
- Partner with customers to develop, review, approve, and execute method transfer into the chemistry and/or microbiology laboratory, including tracking of all deliverables relevant to the method transfer plans.
- Attend and represent the QC Method Transfer team at cross-functional internal and external project team meetings and ensure team focus on key decisions and milestones and drive accountability to achieve goals.
- Actively manage projects to achieve key performance indicators and proactively discuss any corrective courses of action with customers and internal team.
- Partner with the Director Quality Control to assess QC laboratory capabilities to proactively plan for expansion of both instrumentation as well as personnel.
- Identify and manage significant risks, develop mitigation plans, bring clarity and solutions to complex situations with high ambiguity, and lead the delivery of several diverse projects at the same time.
- Work closely with Business Development and Project Management teams to contribute to the generation of Project Plans from Project Proposal documentation.
- As a part of the employee's job requirements, the employee may be required to handle waste including hazardous waste. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.
Candidate Requirements:
- Degree in Chemistry, Biology or Life Sciences.
- 7-10 years’ experience in GMP regulated industry with a minimum of 3 years’ experience in a supervisory role.
- Excellent interpersonal skills, and capable of developing productive working relationships with subordinates, colleagues, customers, suppliers, and partners.
- Representing Quality Control in client facing meetings and coordinating all QC activities as it relates to client project method transfers.
- Be available to participate in client meetings that may go outside of standard business hours (Monday-Friday 8 AM-5 PM).
- Possess strong project management skillset.
- Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.
- Experienced in organizing and leading business and project review meetings with a joint steering committee comprised of senior leaders, representing customers and internal personnel including ability to answer impromptu questions and provide real-time updates.
- Skilled at negotiation and ensuring common understanding of requirements and expectations.
- Ability to respond to the unexpected quickly and constructively, while balancing tact, negotiation, and directness.
- PMP/PgMP certification.
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
