Process Development Chemist
Specific Duties and Responsibilities:
- Aid in planning and developing feasible and cost efficient downstream processing operations in support of both new and existing products.
- Assist in the planning and purchasing of new equipment and materials in support of Process Development and cGMP Production activities within the Manufacturing Group.
- Responsible for reporting process development results and assessments in a suitable proposal format as deemed appropriate in support of new and existing products.
- Aid in the transfer of relevant process procedures and technologies for routine utilization in the production of materials under cGMP guidelines and for training personnel as needed with regard to such procedures.
- Assist in the training of new personnel with regard to Process Development activities in support of high quality and high productivity requirements.
- Aid in creating, editing and reviewing pertinent documentation in support of Process Development activities as needed.
- Assist in creation, implementation and training of technical documentation, e.g. standard operating procedures, development reports, protocols, etc.
- Assist with the development, coordination and execution of equipment qualification and monitoring of process validation activities in accordance with regulatory requirements.
- In cooperation with designated senior staff, participate in the introduction of new ideas and methods according to company and site policy.
- As needed, work in a GMP environment to develop and transfer peptide purification process development strategies consisting of chromatography, crystallization, lyophilization, and other relevant techniques.
- As needed, follow approved instructions such as Batch Records, Standard Operation Procedures, Standard Test Procedures, etc.
- Install, test, operate and maintain equipment for process development, manufacturing and in-process testing as needed. Equipment may include analytical, semi-preparative and preparative scale HPLC systems, lyophilizers (manifold and tray type), balances, rotary evaporators, dialfiltration systems, etc. used in support of manufacturing processes.
- Aid in the investigation and troubleshooting of process deviations.
- Must be willing to work shifts and weekends as necessary to complete assigned tasks.
- Other duties assigned as needed.
The successful candidate must be able to work on multiple projects and meet established timelines. Qualified candidate should have a BS/BA in chemistry or related field, preferably with 1-2 years experience in a Manufacturing/cGMP environment. Candidate must be familiar with both CFR 21 and ICH guidelines with regards to cGMP manufacturing of active pharmaceutical ingredients and/or drug products. Candidate must possess strong computer, interpersonal, communication and attention to details skills.