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Title: Senior Scientist/Engineer II
Location: Waltham MA
Duration: 12 Month Contract
Start Date: ASAP
Purpose
The scientist will apply scientific, engineering principles and statistical process design/analysis to develop robust ADC manufacturing process hands-on. The candidate must have in-depth knowledge and experience including but not limited to late-phase process transfer, process validation, process improvements, etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.
Responsibilities
- Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
- Identify and implement technical innovations to improve product quality, improve yield, qualify new material suppliers, reduce cost and/or enhance the intellectual property landscape.
- Support CMC life cycle management and post-approval continued process validation for commercial DS.
- Support/ lead new product introduction into the manufacturing area at internal sites or at third-party manufacturers, ensuring successful tech transfer, scale up and validation for the product.
- Collaborate with process development for late-stage technology transfers, scale-up activities, and process validation during the transition to commercial manufacturing.
- Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
- Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
- Represent the MSAT ADC group in CMC program teams. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
- Design, execute and analyze experiments using a robust scale-down model for continued process improvement of late-phase/commercial ADC biologics products.
- Responsible for compliance with applicable Corporate and Divisional policies and procedures.
- Travel will be required (up to 25%) in support of tech transfer activities and routine manufacturing.
Qualifications
- BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry or closely related field with typically 12+ (BS), 10+ (MS) or 4+ (PhD) years of postdoc or industry related experience.
- Experience in areas of bioprocess development, validation, regulatory submissions, and manufacturing support.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent communication, writing and presentation skills are required.
- Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve.
- Demonstrated knowledge of GMP and experience providing technical support in a GMP manufacturing environment
- Demonstrated ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Senior Scientist/ Engineer II Waltham, MA
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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