Senior Advisor - Bioprocessing
Part-Time 20 Hours
Mapp Biopharmaceutical, Inc. "Mapp" is a biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Senior Advisor - Bioprocessing is responsible for providing deep technical expertise and assisting in the management of mammalian process development and contract manufacturing organization (CMO) activities in the Mapp Biopharmaceutical Bulk Drug Substance area.
- Ph.D. in a relevant discipline such as Chemical Engineering, Biomedical Engineering, Biochemistry, Molecular Biology or equivalent required
- 25-years minimum of relevant industrial experience in Downstream Purification (DSP) process development and support of internal or external GMP manufacturing and process validation of therapeutic biologics Drug Substance including recombinant protein, fragment antibody, monoclonal antibody, and/or antibody-drug conjugate
- Experience leading microbial or mammalian-derived downstream purification process development and optimization, scale up, technology transfer, process validation, process mapping and characterization, and manufacturing activities at small scale at internal or CMO laboratories and Phase 1-3 clinical scale or commercial scale at 1st Party, 2nd Party or 3rd Party sites
- Established track record of sustained performance and deliverables for development and GMP manufacturing of mammalian processes at internal or external clinical/commercial manufacturing sites in a small, mid to large Pharmaceutical / Biotechnology organization
- Experience in process development and GMP manufacturing of recombinant proteins, Fab, mAb will be a strong plus
- In-depth knowledge and hands-on biotechnology industry experience in development and manufacturing and process validation of plant or mammalian processes
- Knowledge of the applicable global Change Control, Investigations, and Deviations regulations, cGMP, ICH, and Quality Systems
- Detail oriented with proven organization, prioritization and collaboration skills
- Ability to cultivate excellent cross-functional collaborations, effectively communicate at multiple levels of the organization
- Ability to work independently in a virtual team environment as well as within multi-disciplinary project team
- Experience leading a group of scientists and engineers with diverse technical and educational levels, managing development activities for mammalian production and being accountable for providing technical expertise to achieve the deliverables necessary from the development phase to regulatory filing for commercialization
- Experience having executed tech transfer and GMP production for Phase 1-3 clinical and/or commercial manufacturing at CMOs for mammalian-derived biotechnology derived Drug Substance
- Experience in Process Modeling, COGs analysis, Process Improvement, Lean Six Sigma, Production Planning/Scheduling, and demonstrated use of DOE, QbD, and FMEA are a plus
- Strong leadership, prioritization, quick decision-making, people management skills
- Outstanding written/verbal communication and presentation skills are essential
- Ability to manage multiple projects in a dynamic team environment which requires creativity, innovation and thinking outside the box
- Ability to influence colleagues and leaders in various departments
- Customer focused, passion to succeed and promote team work with high integrity
- Provides technical input and expertise to cross-functional project teams, prepares written and oral presentations, authors/reviews/approves protocols/reports and collaborates/interacts with internal customers including other functions within DSP as well as Project Management, Research, Legal, Regulatory, Quality, and Manufacturing/CMO's
- Assists the DSP group in providing technical leadership at CMO's through effective coaching and development
- Provides technical input on mammalian process development, characterization, and scale-up, including process mapping and characterization from early to late-stage process development
- Leads or co-leads manufacturing oversight at contract sites up to regulatory submissions, and technical support during commercial manufacturing
- Advises, conducts and/or oversees laboratory studies to define downstream purification process parameters for scale up, tech transfer and GMP manufacture of process consistency and Phase 1 to 3 and commercial Drug Substance batches in adherence to technical excellence, corporate goals, project timelines, global regulations and quality compliance
- Provides technical input into the DSP group for deliverables from the development phase to regulatory filing for commercialization
Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in Carmel, Indiana or may have the opportunity to work remotely. Mapp wants you to join their team and invites you to apply.
No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.
Mapp is an Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.