Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Will work with hazardous/toxic materials
Job Description
Summary:
Investigates, creates, and validates new scientific methodologies used to manufacture and control raw materials, production intermediates, and final products. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on significant technical/scientific project activities to implement strategies and technical solutions that meet client's expectations through broad expertise. Engages in creation of processes and equipment design for clinical, scale up, registration and/or commercial production batches.
Essential Functions:
Develop feasible chemical processes to synthesize drug intermediates and APIs that meet or exceed the quality requirements from clients.
Collect reliable process data through designed laboratory experiments with accurate, detailed documentation for process evaluation, development and troubleshooting.
Record and analyze scientific data/observations in detail. Summarize and interpret process data to draw logical conclusions. Write technical updates/reports. Participate in technical discussions with internal teams and clients.
Proficient analytical knowledge for compound identification and structure elucidation is required including at least NMR, IR, HPLC, GC, and MS.
Prepare detailed process development report to support manufacturing and regulatory requirements.
Draft and review Operating Instructions, Deviations, Change Controls, and Investigative documentation.
Implement Operating Instructions for laboratory scale production under SOP/cGMP guidelines.
Provide timely technical support for scale-up production, quality and other inter-departmental needs.
Fit in a multidisciplinary team with flexibility to carry out fast-turnaround projects.
Research industry practices and processes and apply to innovative development internally and for client products.
Lead projects with minimal direction. Manage project timelines
Education:
PhD in Chemistry or relate discipline; Master's degree with commensurate experience will be considered
Experience:
Experience working in Pharmaceutical Industry preferred.
Strong knowledge and understanding of chemistry and analytical instrumental technologies.
Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
Problem-solving skills and logical approach to solving scientific problems.
Proficiency with HPLC, GC, LC/MS and Dissolution techniques.
Excellent interpersonal and communication skills (both oral and written); ability to present information to customers, clients, and other employees.
Ability to read, analyze, and interpret technical procedures and governmental regulations.
Competencies:
Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Good problem-solving skills and logical approach to solving scientific problems. Proficiency with HPLC, GC, LC/MS and Dissolution techniques. Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.
