QC Method Transfer Manager
Description
This position reports directly to the Director, Quality Control and is a member of INCOG’s Quality Control Leadership Team. The Quality Control Method Transfer Manager plays a vital role on the INCOG team who has a passion for learning, collaborating, and contributing to the success of our 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 our clients.
You will work closely with Quality Control 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.
Essential 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.
- Holds self and others accountable for rigorous scientific and quality work standards.
- Advocate for clients by collaborating cross-functionally to schedule sampling, testing, instruments, and personnel to meet customer needs and timelines.
- Independently manage day to day projects and/or method transfer team activities and issues on projects supporting multiple clients.
- 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.
- Provide support for laboratory investigations related to testing performed in the laboratory as necessary.
- Partner with the Director Quality Control to assess QC laboratory capabilities to proactively plan for expansion of both instrumentation as well as personnel.
- Ensure that analysts receive appropriate training and development for both method transfer and method performance.
- Perform personnel management for the Method Transfer Scientists, including goal development, performance management, people development, and coaching/feedback.
- 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.
- Estimate project levels of effort and resource requirements by using standard estimating techniques and tools.
- Work across projects to conduct post-project review and share lessons learned.
- 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.
Special Job 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.
Additional Preferences:
- 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.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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