Skip to content

Job Openings

Analytical Development Manager

Cambridge, MA 02139

Posted: 09/18/2023 Employment Type: Contract Job Category: Scientific Job Number: 582510 Is job remote?: No Country: United States

Job Description

As an Analytical Development Manager, you will play a pivotal role in advancing our mission to develop transformative therapies for rare diseases. You will be responsible for managing analytical method development, transfer and validation activities at contract manufacturing and testing laboratories providing technical direction and oversight to ensure implementation of robust analytical methods. Your expertise in analytical techniques, leadership, and cross-functional collaboration will be crucial in driving our product development programs forward.
Key Responsibilities:
  • Manage the validation of analytical methods for the release and stability testing of late-stage products, ensuring compliance with regulatory requirements.
  • Manage the ongoing method development and transfer activities at/or between CMO/CROs, providing technical oversight and direction and ensuring timely delivery.
  • Evaluate the method readiness and make recommendations for addressing technical gaps prior to validation.
  • Review validation protocols, data and reports and provide timely feedback.
  • Assist with the development and implementation of analytical strategies to support PPQ and BLA readiness activities.
  • Collaborate closely with cross-functional teams, including process development, regulatory affairs, and quality assurance, to ensure seamless integration of analytical activities into the overall development process.
  • Stay current with industry trends, new technologies, and regulatory guidelines related to analytical development for rare disease therapeutics.
  • Contribute to the preparation of regulatory documents, including INDs, NDAs, and BLAs, by providing analytical data and documentation.
  • Manage the relevant timelines to ensure timely and efficient project execution.
Qualifications:
  • Bachelors or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related field with 5-7 years’ experience or a Ph.D. in a related field with 3-5 years’ experience in analytical method development and validation within the biotechnology or pharmaceutical industry.
  • Expertise in a wide range of analytical techniques, such as HPLC, LC-MS, CE, SDS-PAGE, ELISA, spectroscopy, and others.
  • In-depth understanding of regulatory guidelines (e.g., ICH, FDA, EMA) pertaining to analytical method validation, product characterization, and stability studies.
  • Excellent project management skills, with the ability to prioritize tasks and manage timelines.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
  • Ability to work in a fast-paced dynamic environment with changing priorities, forward thinking with flexibility to support multiple development programs simultaneously.
  • Detail-oriented mindset with a commitment to producing high-quality, reliable analytical data.
  • Experience with rare disease drug development is a strong plus.

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.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

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.