The qualified candidate will provide technical support for biotherapeutic products within Quality Control Product Technical Support in Andover, MA. Qualified candidate will have proven organizational and communication skills as well as comprehensive expertise, including hands-on in relevant analytical technologies. In this role, you will be responsible for managing and facilitating analytical activities throughout the lifecycles of biological products. This involves collaborating with cross-functional teams to achieve site objectives, providing analytical support of products and processes, assisting with regulatory submissions and responses, as well as authoring and reviewing technical documentation.
What You Will Achieve
In this role, you will:
Authoring and reviewing GMP documents and reports
Overseeing qualifications, assessing period of use and managing extension of reference materials
Supporting change control, reagent study and instrument validation, as well as fulfilling commitments
Authoring periodic review of method validations and annual product reviews.
Managing method improvement, new technology implementation and lifecycle activities
Facilitating and performing method qualifications / validations / verifications, method transfers, and comparability studies
Providing audit support for Board of Health inspections and regulatory responses
Ensuring adherence to timelines and deliverables to support product manufacturing
Identifying continued improvement (CI) opportunities, resolving technical issues and monitoring the methods of products
Participating in investigations / root cause analysis and resolution regarding analytical issues
Collaborating across functional areas and other Pfizer Biotech Network sites
Here Is What You Need (Minimum Requirements)
BA/BS with at least 6 years of experience or MBA/MS with at least 4 years of experience or PhD/JD with any years of experience
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 and auditing procedures
Possesses an in-depth understanding of protein characterization and production processes.
Has prior experience in method improvement, including designing studies to enhance method robustness
Displays extensive knowledge in protein analysis techniques, including HPLC/UPLC, peptide mapping, CE/gel, carbo analysis, ICE, and UV.
Experience with ELISA and bioassay methodologies is considered advantageous.
Bonus Points If You Have (Preferred Requirements)
Knowledge of industry standards and ICH, and applicable guidelines in validation and life cycle management
Validation experience
Experience in laboratory automation
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
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, includingrisk management and ethical use
PHYSICAL/MENTAL REQUIREMENTS
Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.
Other Job Details:
The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site 6 U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Quality Assurance and Control
