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Associate Scientist II (Biopharma)

  • Permanent
  • Anywhere

Website Cambrex

Cambrex

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

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—————————— Job Description ——————————

 :
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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