Senior Analytical Chemist – Drug Product Development

2 weeks ago

Cranbury, United States Exemplify Biopharma, Inc., a Symeres Company Full time

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

  • 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.


Requirements

  • 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.


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 careers@exemplifybiopharma.com.


  • Senior Analytical Chemist – Drug Product Development

    3 weeks ago

    Cranbury, United States Exemplify Biopharma, Inc., a Symeres Company Full time

    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...

  • Chemist

    2 weeks ago

    Cranbury, United States ANI Pharmaceuticals, Inc. Full time

    Job DescriptionJob DescriptionAbout the RoleWe seek a highly motivated and experienced Chemist to join our ARD and Quality team. The ideal candidate will have a master’s degree in chemistry/ pharmaceutical sciences and 3-5 years of experience in a GMP environment. Expertise in HPLC with Empower, dissolution, and other analytical techniques is...

  • Chemist

    2 weeks ago

    Cranbury, United States Catalyst Life Sciences Full time

    Our client is urgently looking for Chemists of varying experience. These are on-site positions in the greater Cranbury NJ area. You should apply if you have: B.S. in Science related discipline 2+ years of experience in pharmaceutical lab setting Experience with analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and wet chemistry methodsExperience...

  • Chemist

    2 weeks ago

    Cranbury, United States Catalyst Life Sciences Full time

    Our client is urgently looking for Chemists of varying experience. These are on-site positions in the greater Cranbury NJ area. You should apply if you have: B.S. in Science related discipline 2+ years of experience in pharmaceutical lab setting Experience with analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and wet chemistry methodsExperience...

  • Analytical Research and Development Sr. Scientist or Principal Scientist

    2 weeks ago

    Cranbury, United States Tulex Pharmaceuticals Inc. Full time

    Company DescriptionContact: fliu@tulexpharm.comTulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can...

  • Analytical Research and Development Sr. Scientist or Principal Scientist

    4 weeks ago

    Cranbury, United States Tulex Pharmaceuticals Inc. Full time

    Company DescriptionContact: fliu@tulexpharm.comTulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can...

  • Analytical Research and Development Sr. Scientist or Principal Scientist

    4 weeks ago

    Cranbury, United States Tulex Pharmaceuticals Inc. Full time

    Company DescriptionContact: fliu@tulexpharm.comTulex Pharmaceuticals is a specialty pharmaceutical company based in Cranbury, NJ. We are dedicated to developing and marketing innovative drug products for needy patients. Founded in 2014, our company has rapidly expanded from a Research and development entity to a fully functional cGMP facility that can...

  • Java J2ee Developer

    1 month ago

    Cranbury, United States Avancer Corporation Full time

    Position Java J2EE Software DeveloperAvancer Corporation is seeking a Java/J2EE developer who can independently develop implement and maintain complex technology solutions.Key responsibilities Works from technical specifications to independently develop modify configure and maintain complex software products. Formulate and manage system scope and...

  • Java J2ee Developer

    1 month ago

    Cranbury, New Jersey, United States Avancer Corporation Full time

    Position Java J2EE Software DeveloperAvancer Corporation is seeking a Java/J2EE developer who can independently develop implement and maintain complex technology solutions.Key responsibilities Works from technical specifications to independently develop modify configure and maintain complex software products. Formulate and manage system scope and objectives...

  • Senior Business Analyst

    2 days ago

    Cranbury, United States MJH Life Sciences Full time

    At MJH Life Sciences our success is measured by your success! If you set your standards high and want to contribute to a winning team, we'll provide you with every opportunity to help grow our company and your career. Our associates come from all backgrounds, sharing one key quality: determination to succeed. We value being Service Focused, having a Passion...

  • Jr Product Development Chef

    4 weeks ago

    Cranbury, United States Archer Daniels Midland Company Full time

    Cranbury NJ - New Jersey Research & Development **Jr Product Development Chef - Cranbury, NJ** This is a full-time, exempt position. **Position Summary**: - Provide innovative, state of the art, on-trend and flawlessly executed Culinary solutions to support sales growth across all categories of products around the globe - Embraces a world-class mentality...

  • Director, Real World Data Analytics

    2 months ago

    Cranbury, United States Rocket Pharmaceuticals Full time

    The ideal candidate is a leader who can successfully develop and manage a diverse team. You will solve client problems while providing exceptional service and help develop new business opportunities.  ResponsibilitiesServe as a senior counsel and account leader for senior level clients Ensure annual profit, efficiency, and quality goals are attained at...

  • Senior Director, AAV Cardiovascular Marketing Lead

    5 days ago

    Cranbury, United States Rocket Pharmaceuticals Full time

    Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are...

  • Gmp Chemical Operations Scientist

    2 weeks ago

    Cranbury, United States Porton USA, LLC Full time

    **Job description** Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering...

  • Business Development Representative

    4 days ago

    Cranbury, United States SellerCloud Full time

    Established in 2010, Sellercloud is a Software-as-a-Service company that provides inventory and order management solutions for internet retailers, combining a set of technologies around Innovation, Intelligence and Integration. Sellercloud has grown rapidly, with hundreds of eCommerce clients around the world now managing their inventory and sales through...

  • Business Development Representative

    2 days ago

    Cranbury, United States SellerCloud Full time

    Established in 2010, Sellercloud is a Software-as-a-Service company that provides inventory and order management solutions for internet retailers, combining a set of technologies around Innovation, Intelligence and Integration. Sellercloud has grown rapidly, with hundreds of eCommerce clients around the world now managing their inventory and sales through...

  • Business Development Representative

    3 days ago

    Cranbury, United States Sellercloud Full time

    Job DescriptionJob DescriptionEstablished in 2010, Sellercloud is a Software-as-a-Service company that provides inventory and order management solutions for internet retailers, combining a set of technologies around Innovation, Intelligence and Integration. Sellercloud has grown rapidly, with hundreds of eCommerce clients around the world now managing their...

  • Business Development Associate

    6 days ago

    Cranbury, United States KLUS PHARMA INC Full time

    Job DescriptionJob DescriptionJob Summary:KLUS Pharma has a rapidly growing portfolio of therapeutic biologics. The development of antibody-based drugs is powered by strong innovation and increasing activities in licensing and development partnerships. The Biologics Business Development group is looking to hire a Business Development Associate at its office...

  • Business Development Associate

    4 weeks ago

    Cranbury, United States KLUS PHARMA INC Full time

    Job DescriptionJob DescriptionJob Summary:KLUS Pharma has a rapidly growing portfolio of therapeutic biologics. The development of antibody-based drugs is powered by strong innovation and increasing activities in licensing and development partnerships. The Biologics Business Development group is looking to hire a Business Development Associate at its office...

  • IT Help Desk Support

    1 month ago

    Cranbury, United States Primera Analytical Solutions Corp. Full time

    Responsibilities: - Administer current IT systems and Implement new IT systems. - Manage and monitor data backup, archive, and restore procedures. - Program and manage scripts to automate routine functions. - Assist in instrument calibrations and operations. - Write and review IT-related standard operating procedures. Qualifications: - Associate Degree or...