Planet Pharma ยท 2 days ago
Senior Scientist
San Mateo, CA
Full-time
Onsite
Mid, Senior Level
$175K/yr - $185K/yr
3+ years expPlanet Pharma is seeking a Senior Scientist in Formulation Development. This role involves establishing a state-of-the-art laboratory and collaborating with various teams to develop lipid-peptide and lipid-protein formulations while ensuring compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Valerie Meissner
Responsibilities
Establish state-of-the-art process development laboratory that develops lipid-peptide and lipid-proteins MLV formulations. Ensure efficient and safe lab operations
Hire and mentor staff and manage direct reports
Provide guidance and hands on support for the design and optimization of lipid-peptide and lipid-protein MLV formulations
Ensure effective communication and coordination with our GMP partners to meet project timelines and quality expectations
Prepare and review documentation describing development efforts for regulatory submissions (INDs, BLAs, NDAs). Ensure adherence to regulatory requirements
Work closely with R&D, Regulatory, Quality Assurance, and Manufacturing teams to integrate formulation science efforts within overall project goals
Address and resolve complex process issues during development and manufacturing
Stay updated on advancements in process engineering equipment, techniques and industry trends
Qualification
Required
A Ph.D. in Chemistry, Engineering, Biochemistry or related field
3-10 years of process development experience
Experience in lipid formulations, liposomes, or related drug delivery technologies, including homogenization and lyophilization is a plus
Good understanding of formulation / process (homogenization/microfluidization, TFF, lyophilization), hands on operation/SME or owner of equipment/process, designing experiments
Experience in technical writing is required
Excellent written and oral communication skills
Preferred
Authoring CMC dossiers for FDA, EMA, and other regulatory agencies is a plus
Knowledge and experience in drug-device development, inhalation drug delivery is a plus
Proficiency in formulation design and equipment required for lipid-peptide / lipid-protein formulations
Experience with drug-device combination products is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase