About the Opportunity
We are looking for a Process Developmet Scientist lll for an innovation-driven, fast-growing oral solid dosage (OSD) CDMO known for its science-first mindset, entrepreneurial culture, and hands-on approach to solving complex drug development challenges. The organization partners with emerging and established biopharma companies to design, develop, and manufacture differentiated oral solid products — from early development through commercial launch. Team members operate in a collaborative, curious, and high-accountability environment where advancing therapies and creating value for patients is the core mission.
Core Cultural Values
AUTHENTIC – Be vulnerable, build trust
CURIOUS – Ask questions, be adaptable, speak up
ACCOUNTABLE – Own it, meet commitments, communicate transparently
COLLABORATIVE – Engage others, stay open-minded
FLEXIBLE – Listen actively, make thoughtful decisions
CARE – Be passionate, act with integrity
BLAZE TRAILS – Push boundaries, challenge constraints
EXCELLENCE – Learn, improve, create value
FOCUS – Pay attention to details, deliver exceptional service
How You Will Make an Impact
- Independently lead development activities across client projects from preclinical through Phase III and registration.
- Create phase-appropriate strategies for customer-defined product development programs.
- Execute prototype, scale-up, and process transfer activities including manufacturing, data evaluation, troubleshooting, and risk assessments.
- Write, review, and approve cGMP documentation (batch records, protocols, SOPs, pharm dev reports, investigations, etc.).
- Apply QbD principles, design of experiments, and statistical tools to support drug product development.
- Maintain expert knowledge of equipment and processes relevant to pharmaceutical development.
- Monitor emerging formulation technologies and conduct literature/patent reviews to inform development plans.
- Operate in a GMP environment with diverse compounds (including high-potent and controlled substances).
- Collaborate closely with Analytical Development, QA, Project Management, and Validation groups on cross-functional initiatives.
- Serve as a technical lead on product development project teams and mentor junior scientists.
- Lead continuous process improvements and support scheduling of group activities.
- Demonstrate reliable attendance and professional communication with stakeholders while embodying cultural values.
What You Will Bring
- Bachelor's degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 8+ years of oral solid dosage formulation/process development experience (Master's with 6+ years acceptable).
- Hands-on expertise in formulation and process development for tablets, capsules, and multiparticulates.
- Strong theoretical foundation in pharmaceutics and physical organic chemistry.
- Proven knowledge of excipient functionality, formulation strategy, and unit operations.
- Experience applying statistical DoE for process optimization.
- Excellent written, verbal, and technical communication skills.
- Familiarity with MS Office and statistical tools such as JMP or Minitab.
- Knowledge of GLP/cGMP and regulatory guidance (FDA, ICH, EMEA) related to oral solid dosage.
Special Conditions
- Some travel required (client meetings, conferences, cross-site collaboration).