Pfizer Scientist, Analytical R&D in Andover, Massachusetts
The qualified candidate will be a scientist in an analytical organization (Analytical R&D) seeking to lead the industry in technologies applied to advance biotechnologically-derived products to the market through innovation and delivery of cutting edge analytical testing. The qualified candidate will be part of an organization that focuses on method validation and transfer of analytical methods and technologies for biological therapeutics.
The group is responsible for the validation and late-stage analytical lifecycle management of quality controlled methods as they are established in commercial manufacturing sites. Qualified candidates will deliver results in a fast paced matrix-oriented setting, and be a contributor to method validations and strategies. The role is in support of products and process development for biotherapeutics and vaccines, including antibodies, antibody-drug conjugates, and therapeutic proteins, in late-stage clinical development. The candidate will work across analytical functions, projects, and interface with global sites. The candidate will also primarily author, execute testing and oversee documentation associated with method validations and transfers.
Development and validation of analytical methods, covering a wide array of techniques such as ELISA, qPCR, HPLC, CE, and wet-chemistries.
They will be involved to ensure the proper and timely execution of all aspects of the validation activities to support process qualification and commercial launch.
Lead or be involved in cross-functional analytical technology transfer teams across many sites in the United States and Europe. These teams are responsible for the planning, coordination, execution, and communication of analytical responsibilities.
Will serve as an analytical and biochemistry resource for the department and project teams, proactively keeping colleagues at the commercial launch sites aware of historical product knowledge and experience such as specifications, stability, reference materials, and any method development documentation.
Individuals in this group will be the primary authors, reviewers, and approvers of regulated documents such as method validation reports, protocols, method transfer exercise reports.
Colleagues in this group are expected to be updated with current scientific trends, strategies, and technical aspects from conferences, local meetings, and the literature. Furthermore, the candidate will be responsible for the development of novel approaches and methods with the latest analytical technologies for more informative and efficient product characterization in alignment with commercial manufacturing organizations.
Master's Degree with 2-4 years of experience or Bachelor's Degree with 3-6 years of experience. Concentration of degree in either biology, biochemistry, immunology, molecular biology, analytical chemistry, or related field
Experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics.
Demonstrated technical writing skills and effective communication are strongly desired.
Experience with technologies focused on analysis of biomolecules and conjugates such as HPLC, and electrophoresis.
Experience working in a regulated environment (e.g. GLP, cGMP). Experience with method validations and method transfers to commercial manufacturing receiving labs.
Direct experience working with late-stage clinical development or approved products.
Knowledge and experience in Critical Quality Attributes (CQA) principles and practices and product specifications and specification setting.
Demonstrated technical skills and scientific expertise in analytical method development and troubleshooting.
Able to deliver results in a fast paced environment and effective communication to project teams.
Desire to train and develop colleagues, comfortable delegating
Change agile, functional in a fast-paced team environment where multi-tasking required
Enthusiastic about communicating to a broad range of stakeholders (from novices to experts) and seeking agreement in complex situations
Curiosity about seeking and applying current relevant scientific literature
- Position requires occasional light lifting and periods of standing, sitting or walking, ability to perform mathematical calculations and ability to perform complex data analysis .
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Occasional work-related travel may be needed.
Other Job Details:
Last Date to Apply for Job: December 31, 2018
Additional Location Information: Andover, MA
Eligible for Employee Referral Bonus: Yes
EEO & Employment Eligibility
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