Senior Manager, Chem-Analytical

Why Patients Need You  

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.  

What You Will Achieve  

At Pfizer, we are always seeking to deliver breakthroughs that change patients' lives. In this role, you'll be working to help us achieve that goal by advancing small molecule drugs to the market through innovation and delivery of cutting-edge analytical testing. You will be part of a team which is focused on rGMP release and stability testing as well as regulatory stability strategies to support product and process development for small molecules, at all stages of clinical development. You will work across analytical functions and projects. 
 
A Senior Manager in Analytical Research and Development GMP Analytics Group you will play an important role during all phases of pharmaceutical development. The qualified candidate will take an active role by leading the analytical GMP testing and compliance strategies and directing lab work for new drug candidates. The candidate will work with cross-functional development teams and apply a variety of analytical testing methodologies to drug substances and products. The candidate should be proficient with a breadth of analytical methodologies with expertise in one or more techniques.  The candidate should also be proficient in GMP practices and a wide variety of software and information systems with a demonstrated ability to learn new techniques and solve complex analytical problems. Experience with digital technologies is also desired.  
 
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.  

How You Will Achieve It

• Manage GMP activities of active pharmaceutical ingredients (API) and/or pharmaceutical drug products (DP) across development phases including manufacturing support, release and stability testing and oversight.

• Lead and collaborate with colleagues and subject matter experts across ARD on GMP activities including release, stability, investigations, and audits to meet all manufacturing and clinical timelines.

• Oversee the GMP release & stability testing of colleagues on your team(s).

• Coach team members on communicating and collaborating effectively with multidisciplinary team members, in presenting GMP data at team meetings and in solving technical challenges & thoroughly performing investigations that arise during GMP activities.

• Drive ARD new ways of working by balancing management of internal/external GMP release and stability testing. Collaborate closely with PSSM partners EDMS-ARD, CRD-GES, DPDS and ARD DP&API to achieve optimized rsource utilization forGMP release/stability testing.

• Critically review stability sections of global regulatory submissions, quality investigations and standard operating procedures/Pfizer Quality Standards.

• Support ARD team members by critically reviewing GMP data in support of projects, evaluation of GMP instrumentation, analytical techniques/approaches, and presentation of technical materials.

• Proficient with a wide variety of software and information systems and exhibits the curiosity to continue learning new techniques to solve complex analytical problems.

• Proficient with a breadth of relevant methodologies including chromatography and dissolution.

Basic Qualifications:

• Ph.D/Masters and a minimum 10 years of experience, or BS  and a minimum 15 years of relevant industrial experience or equivalent education & experience.

• Extensive experience in leading technical and/or compliance teams.

• Supervisory experience with proven track record of coaching and mentoring.

• Demonstrated ability to learn new analytical techniques and solve complex analytical problems.

• The ability to use computational and data visualization tools.

• Demonstrated oral and written communication skills, including visualization of data and publishing results.

• Experience with a wide variety of software and information systems.

• Demonstrated autonomy, judgement and business acumen required for a senior manager

• Prior experience with technical team leadership and/or new technology champion

• Candidate demonstrates a breadth of div