Scientist/Senior Scientist, Analytical Development
What’s in it for you?
We have an immediate opening for a Scientist / Senior Scientist to join our Analytical Development group. This individual will be responsible for assay development and analytical characterization of glycosylated recombinant proteins using techniques such as HPLC, mass spectrometry, capillary electrophoresis. This will include the development, optimization and initial qualification of the methods and will also be required to provide analytical support to other functional groups within Acceleron Pharma. This person should be highly motivated, able to work both independently and in a team environment.
What will you be doing?
- Develop analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies and release/stability criteria for various scenarios including accelerated product development.
- Designing and performing analytical method development and validation employing phase-appropriate approaches at different stages of development (pre-clinical through Phase III).
- Providing characterization support for DS and DP for early and late-stage development programs.
- Development of high throughput and robust analytical techniques.
- Support tech transfer of methods to QC testing facility and to CRO/CMO’s
- Provide characterization and assay support to Quality Control for GMP assay analysis, method development and transfer, reference standard qualifications, and DS/DP stability samples.
- Actively participate in CMC regulatory writing activities for analytical development function; assist in review of regulatory filings in INDs/IMPDs, CTAs and BLAs to ensure that CMC related changes are reported to authorities in accordance with regulatory requirements; track analytical development /QC commitments.
- Participate effectively in cross-functional collaborations with Quality and Research groups and with external CROs and CMOs to share workflows and knowledge base.
- Function as analytical team lead, overseeing the program-based development activities and driving the technical agenda
- Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
- Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results
What are we looking for?
- Senior Scientist level Requirements: Bachelor’s degree in Analytical Chemistry, Biochemistry, or Pharmaceutical Sciences with at least 15+ years of industrial experience in the relevant analytical technologies and biologics development - OR - Masters' degree 8+ years of industrial experience or Ph.D. with at least 5+ years of industry experience.
- Scientist level Requirements: Bachelor’s/Masters degree in Analytical Chemistry, Biochemistry, or Pharmaceutical Sciences with at least 10+ years of industrial experience in the relevant analytical technologies and biologics development - OR - Ph.D. with at least 1+ years of industry experience.
- Extensive experience with a broad spectrum of analytical techniques for protein characterization of size, charge, glycosylation, and biophysical properties of biotherapeutics
- Experience in the development of various biotherapeutic modalities, including fusion proteins, MAbs, bi-specifics, and single chain variable fragments (scFv)
- Prior experience with late-stage CMO tech transfer activities and experience with CMO/CRO management throughout the product lifecycle
- Solid background in carbohydrate and glycosylation biology the use of analytical methods for qualitative and quantitative characterization
- LC-MS based peptide mapping characterization experience for post-translational modifications is highly preferred
- Experience authoring analytical sections for regulatory filing; e.g. IND, IMPD, and BLA for DS and DP
- Experience drafting, reviewing and submitting required documentation pertaining to the cGMP environment
- Ability to work collaboratively with others across all functions and levels within the organization
- Ability to work independently and with flexibility to handle work flow in a fast-paced environment
How will you grow with us?
With key regulatory milestones approaching for the lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. It will be a time of dynamic growth, requiring timely, strategic decision making and execution. The Analytical Development group is constantly working on critical projects and activities and is looking for a team member who is excited about our science and initiatives. By joining our innovative and fast-paced environment, you will have the opportunity to contribute to the strategy of the Analytical Development group, gain significant hands on experience on analytical tools, and take molecules from discovery through commercialization. Join our team!
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
*Recruiters - please do not send unsolicited resumes to this posting.
FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:
Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL® (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial. For more information, please visit https://acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.