Company : Veranova
Country: United States
Location : Devens, Massachusetts
Post: Fri, 12 Aug 2022 04:19:07 GMT
Expires: Fri, 09 Sep 2022 23:59:59 GMT
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—————————— Job Description ——————————
Entry level PhD position for process research and development. A process research and development chemist is responsible for enabling the manufacturing of Active Pharmaceutical Ingredients (APIs) under cGMPs on larger scales in a safe and reliable manner through creating an understanding of how chemical processes work and how those chemical processes will translate from a laboratory to a manufacturing environment. The Scientist position requires the application of in-depth chemistry knowledge and standard laboratory techniques and procedures as well as an ability to make keen observations to solve more complex technical issues while learning about how other factors such as cGMPs and manufacturing equipment influence processes and decision making.
Performs scientific experiments aimed at optimizing and developing the necessary understanding of complex chemical processes to enable larger scale manufacturing of APIs.
Develops an understanding of laboratory and process safety equipment and techniques.
Independently evaluates scientific techniques and procedures for solving problems based on literature research, consultation and collaboration with peers.
Applies chemistry knowledge to solve standard chemistry problems without instruction and receives guidance on new assignments or more complex process development problems from a senior team member or supervisor.
Learns technical proficiency, thinks independently, exercises sound judgments that correspond with experience, and adheres to safe work practices.
Becomes familiar with the variety of analytical techniques used to generate data that support the appropriate level of understanding of chemical processes such as NMR, HPLC, UV, GC, LC-MS, DSC, XRPD and KF.
Develops an understanding of current Good Manufacturing Practices (cGMPs)
Documents experiments and results in laboratory notebooks or other designated forms.
Prepares summary reports on findings with guidance from a senior team member or supervisor.
Presents scientific results and observations to team leader and participates in client conferences and meetings.
Gains an understanding of project management activities including: purchasing of materials and meeting timelines, budgets, and project goals.
Learns and follows all Standard Operating Procedures (SOPs).
Other duties as assigned.
Becomes technically proficient and self-assured in applying cGMP standards.
Applies cGMP concepts in association with department specific responsibilities.
Ensures all documentation produced is in compliance with governing SOPs.
Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities.
Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards.
Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities.
PHYSICAL DEMANDS & WORK ENVIRONMENT
While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
Must be able to lift and/or move up to 50 pounds.
Specific vision abilities include: near, distance, peripheral, color perception, and the ability to adjust focus.
Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
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