Under guidance of the Chief Medical and Scientific Officer, the candidate will take the lead in the design and performance of research targeting the development of new products from human breast milk, or its co-products targeting strategic new therapeutic and clinical applications. The position requires high level understanding and experience in biology, biochemistry, molecular biology and protein chemistry and related fields with knowledge and expertise in process/product development and regulatory compliance. The individual should have demonstrated independence in scientific processes and requisite documentation applied in the industrial setting. The candidate should have experience in building and supervising a research team.
The candidate will perform and supervise bio-sample processing and fractionation, method scale-up. There should be evidence of particular knowledge or applicable knowledge in the biology and biochemistry of human milk, other bodily fluids, cell culture, cell banking, the preparation and analysis of nucleic acids from various media with downstream next generation sequencing with key role in developing and codifying processes for existing and new therapeutic products with regulatory compliance.
This candidate will report to the Chief Medical and Scientific Officer but interact with all levels of management on a routine basis influencing research and development strategy for the company overall. This individual will interface with teams from clinical affairs, regulatory affairs, quality and safety, product and process development, and manufacturing enabling smooth technology transfer from initial product conception, product processing and cGMP manufacture for clinical trials. This position will also entail preparing R+D related documents for CMC/IND aspects of regulatory submissions.The candidate will manage relationships with external CRO and academic centers engaged in selected projects incorporating site visits as necessary.
Primary Duties and Responsibilities
To perform and develop research in collaboration with scientific partners both internal and external to Prolacta. In this position, the development/modification of protocols related to the new and revised therapeutic and nutritional products is the primary goal. The research applied will be based on the application of fundamental scientific principles to therapeutic developmental processes and require a detailed understanding of the science of human milk. These applications will include, but are not limited to, cellular, microbiologic, biochemical, chemical and metabolic approaches enable a broader exploratory platform.
In this position, and in consultation with the Chief Medical and Scientific Officer, the individual will develop experimental plans for identification of critical process parameters related to a range of therapeutic products. This will include the exercise of technical discretion for the design, execution of experiments and interpretation of results. The individual will provide technical and on-the-floor support in the assistance of other laboratory personnel and assist in the troubleshooting of processes and maintain accurate and complete development records and protocols.
The individual will: lead and execute scientific plans both personally and with a team. This will entail the execution of technology transfer projects, resolving processing issues, and conducting technical assessments on process/product impact. Identify assays for product characterization in collaboration with CRO and existing lab personnel.
Make detailed observations, analyze data, interpret results, prepare technical reports, summaries, protocols, and quantitative analyses. Identify and implement necessary changes to processes and reagents for regulatory compliance. Investigate, create and develop new methods and technologies for project advancement and contributes to CMC Master File/IND submissions in collaboration with the regulatory and greater RD team.
Maintains high level of professional expertise through familiarity with scientific literature and novel technologies. Uses scientific and practical concepts in accordance with company objectives to solve complex problems in creative and effective ways.
Communicates in written and oral form with a multidisciplinary team including: Investigators, Scientific Staff, Quality Assurance, Manufacturing, Operations, R&D, etc.
Job Requirements and Qualifications
• PhD in Biology/Genetics/Biochemistry or other relevant field with a minimum of 5 years of experience in a development laboratory.
• At least 7years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance/product manufacturing.
• Experience with Design of Experiment (DOE) and JMP/SPSS or other relevant statistical software.
• Knowledge of FDA and EU cGMP regulations and requirements as they relate to process and assay development.
• Experience in developing assays for transfer into a GMP testing lab,subject matter expert for tech transfer.
• Excellent written, verbal, and interpersonal communication skills.
• Demonstrated ability to work independently and in teams.
• Able to analyze and interpret high-throughput data for new product concepts.
• Be a self-starter with the ability to take on several projects at one time.
• Excellent critical thinking, organizational, and analytical skills.
• Highly motivated, with the ability to work independently and as a leader of a team of either direct reports or matrix-project based reports.
• Adaptability to work in a fast-paced and changing environment
Other Knowledge, Skills and Abilities
- · Strategic planning experience
- · Able to create and manager budget
- · Ability to work without supervision
- · Effectively interview and select candidates
- · Handle conflict management and bring resolution
- · Effective relationship building skills
- · Ability to produce and present clear, concise and professionally written communications and presentations
- · Performance Management, effective coaching and directing of others
- · Positive attitude and motivation
- · Ability to operate in a complex matrix environment
- · Visionary and forward-thinking
- · High level of business acumen
- · Project management
- · Strong PC skills, MS Outlook, Word, etc.
- · Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
- · Strong Critical thinking and decision making skills
- · Strong business ethics
- · Scorecard managementWork Environment (Location, travel, shift, on-call, etc.)
- · This job operates in a professional office environment. This role routinely uses standard office equipment such as laptops, smart phones, photocopiers/scanners, shredders and filing cabinets.
- · This is a full-time position, and hours of work and days are Monday through Friday, 8:30 a.m. to 5 p.m.