Senior Director, Process
The Director / Senior Director of Process will lead the development efforts for our drug substances. He/she will work through contract manufacturers to develop processes, schedule production and create strategies to ensure meeting clinical timelines, regulatory requirements and commercial expectations.
Principal Duties and Responsibilities
• Provide project leadership and technical oversight for development of small molecule APIs through contract manufacturers (CMOs)
• Coordinate activities to ensure a supply of API to meet preclinical and clinical requirements
• Develop a manufacturing process to meet the commercial demands and development timelines of our products
• Develop a supply chain plan to ensure current and future demands
• Work with Analytical, Quality Assurance and Regulatory to develop appropriate control requirements for the drug substance
• Represent API issues within CMC group and cross functional teams
• Directly monitor manufacturing operations at the CMO sites as needed to understand and respond to real-time issues
• Travel 20-50% time depending on location
Education & Experience:
• PhD with 10+ years experience in small molecule API development including process research, development and validation
• Working knowledge of cGMPs and validation methodologies for drug substances
• Direct experience with management of CMOs
• Strong organizational skills and ability to effectively manage multiple priorities and projects
• Good written and verbal communication skills
• Ability to travel domestically and internationally
Scientist II/Senior Scientist, Process Biochemistry
Major Duties and Responsibilities (including supervising others):
Responsible for planning, supervising, and executing a major portion of development activities in the areas of purification process development, scale-up, validation, and technology transfer to clinical / commercial manufacturing. Incumbent will lead a purification development team with responsibilities for several projects in various phases of clinical development, including process validation for clinical/commercial processes. Good working knowledge of protein chemistry, protein purification and process design. Experienced individual with statistical design of experiments as well as identification of critical process parameters and in-process control limits. Must be proficient in protein purification, including folding/refolding, chromatography, filtration, and process characterization. Expected to be knowledgeable in viral clearance, formulation, and product characterization. Team orientation is essential as well as the ability to coordinate efforts with Quality, Validation, Regulatory and other Research and Development groups in order to meet project timelines and company goals. Additional job expectations include ability to analyze and interpret analytical and process data and understand the process implications. Will be expected to identify new process technology methods and carry out the necessary experiments for implementation. Will be expected to effectively evaluate areas for process improvement and process optimization. Experience preparing and/or reviewing INDs, IMPDs, CTDs, BLAs or other regulatory discussion documents is essential, together with a good working knowledge of GMP and Quality issues. Must provide technical support to Clinical and/or Commercial Manufacturing. Excellent oral and written communication skills.
Education: Requires a Ph.D. or equivalent in chemical/biochemical engineering, biochemistry, or chemistry.
Experience: Minimum of 5-10 years of relevant industrial experience
Special Skills/Abilities: Prior supervisory experience is required. Excellent oral and written communication skills is essential. Prior GMP experience is a plus. Able to prepare/review Batch Production Records, SOPs and other process documents. Familiar with computer software including word processing, data evaluation, statistical packages. Familiar with equipment at analytical and process scale. Demonstrated ability to manage complex projects.
Job Complexity: The job is moderately complex, requiring a thorough understanding of the biological and chemical properties of recombinant proteins and monoclonal antibodies. Scientific and/or technical training in chromatography, separations technology and laboratory analytical techniques is required with prior GMP experience, if possible.
Research Associate, Formulation Development
Formulation and process development for preclinical and clinical studies. GMP manufacturing experience is preferred.
Essential Duties & Responsibilities:
Performs a variety of experiments that support research activities in various disciplines. Includes operating scientific equipment, selecting appropriate methods and techniques to perform experiments, analyzing data and preparing related reports. Depending on level of experience may plan and organize details of experiments.Uses established data, reports and previous results to identify inappropriate variances and concerns. Reports inconsistent results to supervisor.Participates in group meetings. May present data or prepare for others to present. Works closely with immediate supervisor on problems that may be of moderate complexity.
Knowledge, Experience & Skills:
Typically requires a BS degree in discipline related to the specific nature of research being conducted, and no experience. Good verbal communication skills and interpersonal skills are required. Must be able to participate in highly effective teams. Requires ability to use common tools for effective scientific communication within the company.
Senior Manager/Associate Director, Analytical Development
The Senior Manager/Associate Director of Analytical Development will be responsible for providing strategic, tactical, managerial and scientific/technical leadership in the areas of Analytical Development and Quality Control.
Summary of Key Responsibilities:
1. Provide Leadership, project management and technical expertise in analytical chemistry across API and drug product for preclinical and clinical development projects.
2. Execute analytical development and stability programs through active management of CRO’s
3. Participate on multi-disciplinary teams and support creation of integrated development programs by providing expertise and driving strategy for analytical chemistry.
4. Work with Corporate partners on analytical strategy and technology transfers.
5. Prepare and implement protocols and detailed project working plans.
6. Review all analytical data and documents and ensure they meet the project requirements.
7. Track and maintain analytical documents and data.
8. Drive operational excellence at contract research organizations (CRO’s) and contract manufacturers (CMO’s) to ensure Phenomix’s expectations around cGMP compliance, product quality and production targets are clearly understood, well documented and consistently met.
1. BS/MS with 8-10 years/Ph.D. with 3-5 years experience in analytical chemistry in pharmaceutical or biotech industry;
2. Hands on experience in analytical method development;
3. Proven industrial experience in managing analytical projects for pharmaceutical projects;
4. Experience managing work at CRO’s;
5. Broad familiarity with CMC activities and regulatory requirements;
6. Proven working knowledge of drug development process;
7. Goal oriented;
8. Attention to detail;
9. Strong planning and organizational skills and an ability to handle multiple priorities;
10. Proven management skills;
11. Excellent communication skills, both verbal and written.
Associate Scientist II/III, Protein Formulation
Biogen Idec is currently looking to fill an Associate Scientist position in the Protein Pharmaceutical Development Department. The successful candidate will assist in protein formulation development activities to support preclinical, clinical and commercial drug development teams. A background in biopharmaceutical formulation development is highly desirable. The candidate will be responsible for supporting protein formulation development activities, including formulation preparation, managing stability studies, analytical testing, and formulation troubleshooting. Hands-on experience in a protein biochemistry laboratory setting, spectroscopy and demonstrated technical ability with electrophoresis and protein HPLC methods are highly desired. Experience in DSC, CD and fluorescence is a plus. This position requires a detailed-oriented individual with good interpersonal and communication skills, who can work well independently and as part of a team in a dynamic, fast-moving development environment.
A BA/BS or MS in Chemistry/Biochemistry/Pharmaceutics/Chemical Engineering or related discipline with minimum of 5 years biopharmaceutical industry experience in a drug product formulations or analytical development environment is required. The candidate should have excellent laboratory, computer, documentation, communication, and organizational skills. Experience analyzing protein solutions with modern analytical methodologies (e.g. HPLC, electrophoresis, and/or spectroscopy) is also required.
BA/BS, or MS in Chemistry/Biochemistry/Pharmaceutics /Chem. E. or related field.