HireMinds
Sr. Scientist, Formulation Development (Solid Oral)
HireMinds, Newark, California, United States, 94560
Sr. Scientist, Formulation Development (Solid Oral)Location:
California (East Bay)On-site commitment:
4 days a week
Job Description:HireMinds is partnered with a biotech company focused on peptide drug development, with a vision of bringing commercial products to market. We are seeking your expertise in solid oral formulation and process development to provide scientific, technical, and hands-on expertise in oral dosage forms. To be successful, you'll have experience across early- to late-stage clinical development and demonstrate expertise in solid dosage formulation techniques.
Your Responsibilities:
Hands-on contribution to the design and development of solid oral dosage forms from early-stage drug discovery through clinical development.Conduct lead optimization, preformulation, and formulation development lab activities.Provide oversight of process development and scale-up for manufacturing clinical materials.Development of efficient, scalable manufacturing processes, and management of drug product development and GMP manufacturing with external CDMOs.Knowledge of global CMC regulatory submissions (INDs, IMPDs, NDAs).Work with Director's supervision to advance state-of-the-art oral drug delivery techniques.Represent pharmaceutical sciences in cross-functional team meetings.Prepare, analyze, and present data for project meetings and support regulatory submissions (IND/IMPD).Conduct laboratory experiments, analyze data, and present results for oral dosage form development.Collaborate with external CDMOs on oral formulation development and manufacturing.Coordinate with quality control, quality assurance, and regulatory teams to resolve technical issues under established cGMP principles and documented environment.Serve as SME and person-in-plant during clinical trial material manufacturing or process development experiments.Expertise in oral formulation development and pharmaceutical excipients for oral dosage forms.Proficiency in modern oral delivery technologies and complex formulations to enhance bioavailability of small molecules or peptides, with preferred expertise in site-specific oral GI focused targeting.Knowledge of various oral dosage forms, such as immediate release tablets, controlled/delayed release tablets, capsules (hard-shelled, liquid-filled, softgels).Work hands-on with techniques, including: tableting, capsule filling, coating, granulation, and blending.Proficiency in physicochemical characterization of oral dosage forms (e.g., disintegration, dissolution, tablet hardness, stability).You'll Bring:PhD in a related formulation or analytical scientific discipline with 7+ years of industry Biotech or Pharmaceutical experience in peptide or small molecule formulation development OR MS 10+ years.Knowledge of analytical techniques (e.g., HPLC, DSC, FT-IR), as well as pharmacokinetics and bioequivalency as related to formulation development.Understanding of packaging materials for solid oral dosage forms. Familiarity with experimental design for process scale-up (e.g., DoE, QbD principles).Ability to travel to CMOs both Domestic and international.Compensation:Salary: $165,000 to $180,000Bonus: 10-12%Stock considerations, health, dental, and 401k plan#J-18808-Ljbffr
California (East Bay)On-site commitment:
4 days a week
Job Description:HireMinds is partnered with a biotech company focused on peptide drug development, with a vision of bringing commercial products to market. We are seeking your expertise in solid oral formulation and process development to provide scientific, technical, and hands-on expertise in oral dosage forms. To be successful, you'll have experience across early- to late-stage clinical development and demonstrate expertise in solid dosage formulation techniques.
Your Responsibilities:
Hands-on contribution to the design and development of solid oral dosage forms from early-stage drug discovery through clinical development.Conduct lead optimization, preformulation, and formulation development lab activities.Provide oversight of process development and scale-up for manufacturing clinical materials.Development of efficient, scalable manufacturing processes, and management of drug product development and GMP manufacturing with external CDMOs.Knowledge of global CMC regulatory submissions (INDs, IMPDs, NDAs).Work with Director's supervision to advance state-of-the-art oral drug delivery techniques.Represent pharmaceutical sciences in cross-functional team meetings.Prepare, analyze, and present data for project meetings and support regulatory submissions (IND/IMPD).Conduct laboratory experiments, analyze data, and present results for oral dosage form development.Collaborate with external CDMOs on oral formulation development and manufacturing.Coordinate with quality control, quality assurance, and regulatory teams to resolve technical issues under established cGMP principles and documented environment.Serve as SME and person-in-plant during clinical trial material manufacturing or process development experiments.Expertise in oral formulation development and pharmaceutical excipients for oral dosage forms.Proficiency in modern oral delivery technologies and complex formulations to enhance bioavailability of small molecules or peptides, with preferred expertise in site-specific oral GI focused targeting.Knowledge of various oral dosage forms, such as immediate release tablets, controlled/delayed release tablets, capsules (hard-shelled, liquid-filled, softgels).Work hands-on with techniques, including: tableting, capsule filling, coating, granulation, and blending.Proficiency in physicochemical characterization of oral dosage forms (e.g., disintegration, dissolution, tablet hardness, stability).You'll Bring:PhD in a related formulation or analytical scientific discipline with 7+ years of industry Biotech or Pharmaceutical experience in peptide or small molecule formulation development OR MS 10+ years.Knowledge of analytical techniques (e.g., HPLC, DSC, FT-IR), as well as pharmacokinetics and bioequivalency as related to formulation development.Understanding of packaging materials for solid oral dosage forms. Familiarity with experimental design for process scale-up (e.g., DoE, QbD principles).Ability to travel to CMOs both Domestic and international.Compensation:Salary: $165,000 to $180,000Bonus: 10-12%Stock considerations, health, dental, and 401k plan#J-18808-Ljbffr