- Author and review technical documents including stability and validation protocols, specifications, test methods, Certificate of analysis/Report of analysis and other technical documents as needed.
- Complete method development, verification and validation including release and stability methods in support of preclinical and clinical development and activities.
- Perform method trouble shooting as required and propose any method improvement requirements during the method feasibility work of client supplied methods and/or during compendial method evaluation for assay, impurities, dissolution etc.
- Analysis of finished products, in-process materials, raw materials under cGMP.
- Perform stability testing on R&D and clinical batches and report/document per applicable specification and stability protocols.
- Collaborate with cross-functional teams including formulation scientists, quality assurance professionals, and regulatory affairs professionals to ensure timely and successful project completion.
- Interface with clients.
- A Ph.D. degree in analytical chemistry or a related discipline with at least 3-5 years of experience in analytical support of formulation development, manufacture and release.
- A demonstrated ability to conduct independent research, solve scientific problems, and lead other professionals in a highly collaborative environment.
- Experience working with solid oral dosage forms (tablet, capsule, solution, suspension), including various release formats IR, ER, DR etc. and topical formulations. Experience with parenteral formulation development is a plus.
- Demonstrated skills/expertise in analytical instrumentation including LC (HPLC, UPLC), KF titrators, dissolution, FT IR, UV-VIS, PSD, GC, LC-MS, XRPD.
- Demonstrated experience in method development, trouble shooting, and validation (HPLC, dissolution, GC, LC-MS) in support of NCE drug product development and release.
- Strong understanding of cGMP regulations and regulatory requirements for NCE drug development, including FDA, EMA, and ICH guidelines.
- Strong written and oral communication skills.
- Ability to manage multiple projects simultaneously.
- Excellent problem-solving skills and ability to work independently.
- Experience working with directly with external clients is a plus.
- Experience in pre formulation and solid state characterization is a plus.
- Experience in providing scientific support for regulatory submission (IND, IMPD) is a plus.
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Senior Analytical Chemist – Drug Product Development - Cranbury, United States - Exemplify Biopharma, Inc., a Symeres Company
3 weeks ago
Description
Exemplify BioPharma, Inc. a Symeres Company is a global partner research organization (PRO) based in New Jersey, USA. We are a team of biopharma industry experts focused on delivering end-to-end Chemistry, Manufacturing and Controls (CMC) throughout the drug development and regulatory market application processes. Using a unique combination of program management, coupled with our New Jersey based R&D laboratories and GMP manufacturing facilities we are ideally positioned to deliver CMC success to partner organizations. We are talent based team and our key asset is our experience, multidisciplinary expertise and proven track record. We strive to bring tangible value to our partners through provision of strategic, tactical and technical leadership to solve complex problems focused on reducing program timelines and costs.
The Role
Exemplify is seeking an experienced Senior Analytical Chemist to join our dynamic drug development team. The ideal candidate will have a strong background in analytical chemistry and at least 3-5 years of experience in support of formulation development and GMP manufacturing of NCE's in the pharmaceutical industry. As a Senior Analytical Chemist, you will play a lead role in developing innovative products for our clients across various industries.
Responsibilities
Requirements
Benefits
Exemplify offers a competitive salary and total benefit package including health, dental, vision, life and short-term disability insurance through APD, including a 401K retirement saving's plan, and paid time off.
Application
This is an exceptional opportunity for motivated candidates who wish to be exposed to all aspects of CMC drug development in a fast moving, collaborative and learning environment. If you are interested in applying for this exciting opportunity at Exemplify BioPharma please e-mail a cover letter and resume to
