Search Jobs
Research Associate - III*
Job Description
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)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
About Oceanside, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.