QC Senior Scientist

Use Your Power for Purpose

Every day, our unwavering commitment to quality and the delivery of safe, effective products to patients drives everything we do. Our science and risk-based compliant quality culture is not only flexible and innovative but also customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. By being part of our team, you help ensure that our products meet the highest standards, ultimately benefiting those who rely on them.

What You Will Achieve

In this role, you will:

• Acts safely and follows all EH&S safety requirements for site and QC laboratories.
• Be recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards. 
• Excellent written and verbal communication skills
• Ability to identify issues, present complex problems with possible solutions, and actively take a leadership role to resolve issues.
• Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information.
• Ability to receive feedback from management and colleagues and take accountability for actions and personal development.
• Aptitude for good decision making based on procedures, guidance, and experience.
• Awareness to know their own limitations and seek senior scientist or management guidance when appropriate.
• Desire to ensure correctness and accuracy in tasks and documentation.
• Fitness of functioning as a team member and performing independent work with minor guidance
• Willingness to use personal skills and knowledge to achieve individual and company goals and objectives.
• Understanding of own area of function and knowledge of other cross functional areas
• Able to create, review, and approve test method and/or equipment validation records with limited guidance/coaching.
• Understands the importance of feedback and receives feedback well from management and other colleagues.
• Makes good decisions based on knowledge of quality systems and technical experience.
• Recognizes the impact of procedural changes that may impact future quality tasks and decisions.
• Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations.
• Responsible for personal timelines and seeks advice if conflicts arise.
• Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines.
• Ability to communicate effectively with good interpersonal skills.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of
  experience; OR a master's degree with at least 2 years of experience; OR
  a PhD with 0+ years of experience; OR as associate's degree with 8 years
  of experience; OR a high school diploma (or equivalent) and 10 years of
  relevant experience 

• Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

• Strong technical understanding/use of laboratory instrumentation function and analytical testing focused on analytical separation methods (e.g. HPLC/UPLC, iCIEF/Maurice, Purity/PA800+, plate-based methods)

• Experience with Laboratory Information Management System (LIMS) and Data review

• Proficiency in handling current MS Office Applications

• Excellent written and verbal communication skills

• Strong interpersonal abilities

• Solid understanding of US, EU, and ROW cGMP & GLP

Bonus Points If You Have (Preferred Requirements)

• Doctorate degree (PhD, PharmD)

• Experience defending laboratory practices in regulatory audits and Quality Operations

• Relevant experience in biotherapeutics (antibodies, vaccines, and gene therapy)

• Familiarity with Lean Six Sigma concepts, Lean Labs

• Experience with project management tools, including stakeholder management

• Strong problem-solving skills

• Ability to work collaboratively in a team environment

• Excellent organizational and time management skills

• Experience in a leadership role within a laboratory setting

• Knowledge of regulatory requirements and quality standards

• Ability to mentor and develop junior team members

PHYSICAL/MENTAL REQUIR