QC Scientist-Biochemsitry/Raw Materials Acceleron Pharma

About Acceleron:

Founded in 2003, Acceleron Pharma, Inc. is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. In 5 years, we have internally discovered and developed 4 products that have entered into clinical trials. Acceleron has raised over $100M in venture financing and secured an additional $170M from collaborations with Celgene Corporation, Alkermes, and Shire. Acceleron?s scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF-? protein superfamily. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company?s internal GMP manufacturing capability to advance its therapeutic programs rapidly and efficiently. The investors in Acceleron include Advanced Technology Ventures, Bessemer Ventures, Flagship Ventures, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock.

We are seeking talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success.

Position Overview:

Quality Control Scientist to lead Analytical Method Transfer/Qualification and Supplier functions. Position will manage quality issues with suppliers of raw materials, services, manufacturing and testing to ensure no impact to quality, supply or regulatory compliance of Acceleron products. Incumbent will serve as owner of raw materials in terms of managing vendor changes, deviations, rejections and regulatory compliance.
This scientist will conduct routine and non-routine analysis of drug substance, drug product, in-process materials, raw materials, method transfer/qualification/validation and stability samples by appropriate biochemical methods. Apply cGMP practices during execution of routine testing. Troubleshoot and optimize analytical methods. Design and perform method qualifications and validations per regulatory guidance. Conduct investigations using scientific techniques. Work independently and achieve problem resolution with minimal supervision.

Job Responsibilities:

Qualify raw materials, laboratories, services, manufacturers and suppliers, and oversee vender performance (in terms of quality and compliance) on an ongoing basis; take action (e.g., disqualify supplier) when necessary
Manager change agreements with vendors, review changes and coordinate appropriate evaluation, testing, implementation and reporting of changes (e.g. Vendor specification, location and process changes)
Procures and maintains animal origin and original location of manufacturing statements, quality assurance and service agreements
Drives resolution of quality issues with vendors (e.g., material rejections and investigations)
Partner with Materials Management on supply issues; Quality Assurance for vendor audits; Quality Control for raw material testing. Participate in vendor meeting and QA audits
Coordinate assessment and implementation of new and existing regulatory/compendia requirements for materials and suppliers
Design and execute method qualifications, validations and transfers per regulatory guidance
Conduct routine and non-routine analysis of test articles as assigned by appropriate biochemical methods such as: SDS-PAGE, HPLC, ELISA, etc.
Conduct document reviews, author standard operating procedures (SOP?s) and assay review
Use scientific expertise to provide assistance for troubleshooting, laboratory investigations and problem resolution. This position will lead troubleshooting and optimization of analytical methods
Provide scientific mentor by sharing experience and knowledge of the product development process (analytical aspect in particular), disseminating technical knowledge and acting as a role model
Demonstrate initiative to perform routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed
Compile data and prepare graphs for documentation of test procedures and preparation of reports
Suggest process improvements to QC management and lead improved process implementations.

Basic Qualifications:

MA/MS required, PH.D. preferred with at least 3 ? 8 years related experience
Laboratory skills: 3 ? 5 years of experience with one of the following: HPLC, CE-SDS; SEC; IEF; EILSA; or related lab skills
3 ? 8 years in a Pharma/Biotech Analytical Development, GMP Support or QC Laboratory
Experience in methods used for protein analysis
Skilled in data analysis and reporting writing
Working knowledge of cGMP regulations, method qualifications, validation and transfer
Strong ability to trouble shoot and optimize analytical methods; able to achieve problem resolution using scientific rational with minimal supervision
Excellent teamwork, attention to detail, verbal and written communication skills
Ability to work independently
Biotechnology manufacturing experience is a plus

Location:	149 Sidney Street Cambridge, MA 02139 United States