Scientist/ Engineer III, Drug Product Development
Scientist/ Sr Engineer, Drug Product Development (Fill Finish) 1338104
Location: Greater Boston Area, MA (Onsite)
Science/ Focus: Biologics
Job Overview: This experienced Drug Product expert will oversee external partners/ CDMO’s to assist with programs in clinical development to facilitate the development and validation of methods and testing, while ensuring that fill/finish unit operations studies with external partners are planned, executed and documented.
Responsibilities:
- Establish test protocols and procedures for container closure options and develop partnerships with external partners, as needed, to support the development of clinical and commercial products.
- Develop and execute studies to evaluate the compatibility of Drug Product with processing materials, container closure components, and sterilization processes.
- Assist in authoring and reviewing regulatory submissions.
Requirements:
- MS with 2+ years or BS with 5+ years of industry experience in pharmaceutical development.
- Strong background in fill/finish unit operation characterization and scale-up, aseptic liquid filling of vials, pre-filled syringes, and/or cartridges.
- Experience with technology transfer and validation for clinical or commercial drug product GMP is ideal
- Knowledge of DoE/ Statistical analysis and GMP or GLP compliance.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Code: TechOps
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.