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Scientist, Biologics Analytical Development (CMC)

Huntsville, AL 35801

Posted: 04/03/2024 Employment Type: Contract Job Category: Scientific Job Number: 603146 Is job remote?: No Country: United States

Job Description


  • Participates and occasionally leads in analytical method development and product characterization of recombinant proteins and conjugated proteins derived from microbial and/or mammalian expression systems.  Performs day-to-day hands on operation for development and optimization of analytical methods.  Characterizes protein molecule and complex protein conjugates using various analytical methods, i.e. HPLC, icIEF, mass spectrometry, etc.  Qualifies analytical methods phase appropriately.  Provides analytical support for upstream and downstream process development.  Oversees the activities at CROs for advanced characterization. Involved in analytical method transfer and qualification/ validation at CROs/CMOs.  Oversees analytical results to support GMP production.  Reviews and/or authors the CMC sections of regulatory filing documents. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Normally receives no instructions on routine work, general instructions on new assignments.
  • Analyzes multiple data sources and draws general, non-obvious conclusions.
  • Requirements:
  • A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted.
  • A minimum of 2 years work experience in a biotechnology/pharmaceutical industry, preferably in analytical development, is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. 
  • Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Must be current and active in field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment.
  • Excellent written and verbal communications and team work skills are essential.
  • Must be able to clearly communicate scientific information both written and oral.
  • Must be able to compose sound written work.
  • Must possess good oral and written communication skills.
  • Ability to present technical information to both technical and non-technical audiences is required.
  • Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities.
  • Strong organizational skills are required.
  • Good computer skills are required. Working knowledge of MS word, Excel, Power point is required.
  • Experience working in an FDA regulated environment and knowledge of current GMPs as they apply to laboratory practices are a plus.
  • Experience with regulatory filings is a plus.
  • Previous management skills are a plus.
  • Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills
  • Certifications & Licenses: CMC
  • Defines problems, develops approaches and develops experiments with sound judgment with minimal supervision.
  • Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Interfaces with various departments and partners.
  • Plans and coordinates activities with other team members. Writes and/or approves complex reports and protocols.
  • Maintains knowledge of regulatory compliance requirements.
  • May assist with implementing organizational systems, identifying capital equipment, and projecting resource requirements.
  • May lead staff or a group, provides training as needed, and ensures adherence to company policies and quality requirements.

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 is an equal opportunity employer. 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 Huntsville, AL

Ready to discover exciting job opportunities in the vibrant Huntsville, Alabama area? Huntsville, known as the 'Rocket City,' is a dynamic hub for innovation and technology, offering a plethora of career growth possibilities. With landmarks like the U.S. Space & Rocket Center and the beautiful landscapes of Monte Sano State Park, Huntsville seamlessly blends cutting-edge science with Southern hospitality. Explore the Huntsville Museum of Art, catch a show at the historic Von Braun Center, or indulge in the local favorite, Alabama white BBQ sauce. Join the Rocket City Trash Pandas fandom, Huntsville's Minor League Baseball team, and immerse yourself in the charming Southern charm that makes this region a unique place to live and work. Start your next career adventure with our curated job listings today!

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.