Duration: 12 months possible hire
Location: Norwood, MA
The position is responsible for supporting the research and development of diagnostic medical devices. Must be able to independently setup and operate machinery for various product development processes. Must conduct product development activities in laboratory as well contribute to scale-up activities. Independently capture the generated data in a scientific format. Must maintain laboratory product development equipment, inventory management, associated facilities and machinery under strict compliance to applicable GLP, GMP, DEA, state and local regulations.
Setup, operate, disassemble, and clean any equipment for unit operations for product without supervision.
Clean workspace after completion of operation.
Perform daily other duties as assigned or requested in assigned work areas within defined time.
Visually inspect the equipment during run to verify the equipment is running within a normal and safe operation.
Maintain equipment parts and supplies in proper condition.
Interact with maintenance and vendors when required to maintain, upgrade, or purchase equipment.
Calibrates equipment per procedures.
Ensures equipment are operated and cleaned properly in accordance with company SOPs.
Manufacture PD experimental batches, according to MBR provided by Scientist, following all required SOPs within defined time.
Conduct, in-process sampling and physical testing of experimental batches.
Record in process data during product manufacturing and document in Batch Record
Perform reconciliation of raw material, and finished product for batch processing; such as determining loss amounts, process yields and accountability and verifying inventory reconciliations according to regulatory requirements and company SOP's for experimental batches.
Document setup, use, and cleaning in appropriate logbooks
Maintain raw materials and supplies according to department procedures
Utilize SAP system to place orders
Modify and update SOPs
2-5 years pharmaceutical experience
Have strong oral and written communication skills, as well as basic computer skills with Microsoft Word, Excel and Outlook
Ability to lift equipment or materials weighing up to 50-70 pounds.
Recognizes product characteristics and problems to watch for.
Strong process/equipment knowledge for some major equipment and demonstrated ability to learn new unit operations.
Setup, operate, disassemble, clean and maintain all equipment involved in formulation and pre-formulation/physical characterization of product.
Perform basic mathematical calculations including addition, subtraction, multiplication, and division. Convert units between metric and English and vice versa.
Follow company policies, cGMP’s, DEA regulations, and SOP’s.
Wears appropriate personal protective equipment and follows all safety regulations and procedures.
Ensures project deadlines and performance standards are established and met.
Working independently as well as in a group requiring minimal guidance of a scientist and/or senior technician.
A self-starter who is able to work independently with minimal direction, and who’s confident enough to ask when clarification is needed.
Proven team player with strong interpersonal skills.
Flexibility to adapt to rapidly changing priorities and workloads. Must be flexible and enjoy new challenges.
An unrelenting attention to detail.