Mechanical Design Engineer
Manufacturing Cambridge, MA
Who are we? Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company’s leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body’s ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension. What’s in it for you?
We are seeking a talented and passionate individual who thrives in a dynamic, fast-paced, team oriented and collaborative environment to be part of our success in the CMC-Operations group. This hire will drive the maintenance, calibration and validation of all relevant equipment used at Acceleron in the production, testing and optimization of novel protein therapeutics. You will also be the key contact for all equipment related inquiries, both internal and external. The position requires a self-driven, personable individual with intellectual flexibility, great communication skills and problem solving mentality to successfully complete multiple tasks. The dynamic CMC-Operations group works collaboratively and is looking for a team member with drive, passion, and the ability to work hard while having fun.
What will you be doing?
- Will manage shutdown project of Acceleron’s clinical manufacturing facility
- Analysis and preventive maintenance of current mechanical systems and equipment
- Wil conduct feasibility studies and testing on new and modified designs of the current clinical manufacturing facility
- Will collaborate with external contractors in the preparation of detailed design, design testing and coordinate plan for installation
- Will provide all supporting design and installation information for the complete documentation package
- Will work alongside internal resources to coordinate validation, calibration and documentation of all equipment used in the testing, manufacturing or optimization of drug substance material
- Will assist with remediation, review or revalidation of existing, new or repaired equipment
- Will provide input and guidance to all associated standard operating procedures (SOP’s), current validation protocols, all equipment related risk assessments and associated GMP documentation
- Will maintain, update and revise, as needed, the electronic equipment data base. Currently managed by Master Control
- Will maintain and manage the current Engineering Document Control (EDC) room and all current and new information associated with Acceleron equipment
- Will develop long range plan to address obsolescence of equipment and replacement strategy, including budgeting, procurement, delivery and installation
- Will be a key contributor to the engineering team in the coordination of all onsite mechanical and maintenance activities
- Will coordinate with external vendors on timing, execution and renewal/implementation of service contracts and work instructions
- Will work closely with the Facilities and Quality functions in order to ensure proper documentation of all new equipment with direct impact on the GMP operations at Acceleron
What are we looking for?
The position requires a B.S. in scientific/technical field (Chemistry, biology or Engineering) with5-7 years of experience. The appropriate candidate must have thorough knowledge and understanding of cGMP’s, FDA and pharmaceutical industry guidelines. Candidates should also have experience with temperature mapping procedures and equipment using validation protocols.