Duties and Responsibilities
- Develop new technologies, processes, and product formulations for injectable and oral dosage forms of pharmaceuticals and biologics. Projects include new product development, current product improvement, and ingredient evaluation.
- Design and conduct pre-formulation studies, formulation development, process development, process optimization, scale up and manufacturing, and solving complex problems.
- Act as subject matter expert with clients and government agencies.
- Design and develop new analytical methodologies.
- Review and compile analytical data.
- Write, generate, and review SOPs, protocols, development reports, and master batch records.
- Help develop processes and assist in evaluating new equipment.
- Validate processes, procedures, and formulations, consistent with GMP requirements.
- Source, develop, and work with outside laboratories and manufacturing facilities to identify and support innovative products and delivery methods.
- Formulate and modify existing formulas to meet regulatory guidelines, cost parameters, and claims.
- Collaborate with others to define project scope, timing, and costs.
- Maintain a working knowledge of industry trends through regular research and perusal of relevant publications.
The successful candidate will also have:
- Creative thinking and strong problem solving skills
- Excellent team and interpersonal skills
- Ability to interact successfully with multiple cultures
- Strong attention to detail and ability to multitask and prioritize assignments
- Ability to work under pressure to meet deadlines
- Willingness to work flexible hours
Required Qualifications
- PhD in Biochemistry or a related field, PharmD, or the equivalent qualification, past industry or equivalent experience.
- Excellent verbal and written communication skills
- 2-5 years’ relevant experience in drug development, including experience in regulatory affairs
- Experience with injectable and oral dosage forms, including sustained release dosage formulations
- Experience with analytical equipment such as HPLC, Mass Spectrophotometer, plate readers, spectrophotometer, fluorimeter, moisture analysis, etc
- Experience using design of experiments (QbD) when developing new formulations.
- Experience in formulation development, process development and/or manufacturing.
- Experience in lyophilization development
- Knowledge of filing NDAs, ANDAs, and/or 505 B II NDAs.
- Knowledge of GMP manufacturing
- Knowledge of FDA requirements for different dosage formulations
Job Type: Full-time
Pay: $75,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Ability to Relocate:
- Woburn, MA 01801: Relocate before starting work (Required)
Work Location: In person