Associate Scientist II (Biopharma)
Company : Cambrex
Country: United States
Location : Durham, North Carolina
Post: Sat, 30 Jul 2022 21:11:53 GMT
Expires: Sat, 27 Aug 2022 23:59:59 GMT
Apply Job : Apply Online
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Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!
Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.
Overview:
As an Associate Scientist II in the biopharmaceutical team, you will work with a dynamic group of scientists supporting analytical method development, phase-appropriate validation, and testing services for viral/cellular based therapies and large molecules.
Responsibilities:
Supports cGMP development and testing services for biopharmaceutical drug substances and drug products at all stages of development
Develops biopharmaceutical assays, bioassays, and validates methods for GMP use
Techniques include but are not limited to: qPCR, virus titer by plaque assay, ELISAs, Endotoxin, total DNA, total RNA, HPLC-(MS, UV, CAD, ELSD, RI, FLD, MALS), SDS PAGE, Capillary Electrophoresis, Western blots, HIAC particle counting, and more
Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments in a growing group in a fast-paced work environment
May spend 60-80% of time in the lab and 40-20% writing methods, reports, protocols, and SOPs
Supports ICH validation and stability testing for a variety of molecularly diverse biomolecules and viral active pharmaceutical ingredients
Execution of analytical testing as per approved protocols, current Pharmacopoeia, and test methods etc.
Work effectively in a team environment to grow capabilities and add value to the customer
Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
May interact with clients to report on method development activities/results
Assist sample management in receiving biological materials and manage samples in LIMS
Qualifications:
Masters degree in Chemistry, Biochemistry, Molecular Biology or similar with 1+ years of related experience, or BS degree with 3+ years related experience, or equivalent combination of education and experience.
Must demonstrate a positive attitude and have experience with biopharmaceutical assay testing in a cGMP environment.
Must be a team player and have strong communication skills.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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