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Senior Research Associate - Biologics Drug Product Development (BDPD)

Oceanside, CA 92056

Posted: 09/27/2024 Employment Type: Contract Job Category: Scientific Job Number: 614533 Is job remote?: No Country: United States

Job Description

Target PR Range: 30-40/hr
*Depending on experience
 
Role: Senior Research Associate - Biologics Drug Product Development (BDPD).

BDPD is responsible to develop and characterize formulations and processes for all biologic drug products in pivotal (P3) and commercial stages; also responsible for short / long term stability assessments, technology transfers to clinical and commercial sites, manufacturing support, in-use and compatibility to support clinical studies.

Seeking motivated, team-oriented individuals with scientific experience in laboratory work related to biologics.

Essential Duties and Job Functions:
  • Perform experiments pertaining to:
  • Protein formulation/stability of various dosage forms (liquid/lyophilized) and configurations (vial/syringe), employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods
  • Scale-down/-up of biologics drug product processes
  • In-use stability and administration
  • Author protocols, technical summary reports/memos and tech transfer documentation defining the manufacturing process and parameters
  • Review Master Batch Records for accuracy and trend process data supporting process development or fill/finish manufacturing operations
  • Execute studies in support of drug product technology transfers to clinical and commercial manufacturing sites
  • Be an effective communicator of ideas, project goals and results at departments/meetings in both written and presentation format.
  • Be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.

Knowledge, Experience and Skills:
  • Degree in Chemical/Biochemical Engineering (or a related engineering discipline) or Pharmaceutical Sciences, and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals.
  • Excellent communication (both verbal and technical) and interpersonal skills are required.
  • Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.

Minimum Qualifications:
  • A minimum of 5+ years of experience with BS degree or 3+ years of experience with MS degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline.
  • A basic understanding of formulation and drug product process development for biologics (antibodies, fusion proteins, bi-specifics, vaccines, antibody drug conjugates, etc.).
  • Previous experience interfacing with biologics drug product manufacturing sites and providing technical support during engineering runs/GMP operations is a plus.

Must Have Requirements/Skills:
  • Experience working with Biologics molecules (proteins, mAbs); experience working with ADC is a plus
  • Protein formulation/stability of various dosage forms (liquid/lyophilized) employing a variety of biochemical and biophysical analytical techniques, such as HPLC, capillary electrophoresis, and/or spectroscopy methods, analytical data analysis
  • Experience with some scale-down/-up of biologics drug product process development activities; buffer preparations, testing using compendial methods (osmo, protein conc., pH, etc.) and UF/DF is a plus

Nice to Have Requirements/Skills
  • Presentation and Documentations (ELNs, technical reports, MEMO, etc)
  • good understanding / experience in biologics drug product process (freeze-thaw, filtration, mixing, filling, lyophilization)
  • some understanding of in-use stability and drug administration process and associated challenges (IV bags, subcutaneous injections)

MISC Information: Team Size - 11 full time employees; approx 20 total in pivotal Biologics DP function

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Oceanside, CA

Start your career adventure in beautiful Oceanside, California! This vibrant coastal city, located in San Diego County, offers an unparalleled lifestyle and an array of job opportunities waiting just for you. Imagine working near the iconic Oceanside Pier, enjoying the renowned Mexican cuisine of the area, exploring the Oceanside Museum of Art, or catching a show at the Star Theatre Company. With a variety of industries thriving here, from tech to tourism, Oceanside is a place where professional growth meets laid-back beach vibes. Dive into our job listings today and discover why Oceanside could be the perfect backdrop for your career success.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.