Scientist II, Process Research & Development (R&D)

What You’ll Do

The Scientist II, Process Research & Development (R&D) supports the development, scale-up, and lifecycle management of drug substance and/or complex materials (e.g., hyaluronic acid–based systems) for injectable products. This role focuses on translating laboratory processes into robust, scalable, and well-controlled manufacturing processes suitable for clinical and commercial production. The role works closely with Analytical, Quality, Regulatory, and external partners to ensure processes are well understood and consistently deliver material that meets quality requirements.

How You’ll Contribute

• Design and execute process development studies to improve robustness, yield, and scalability of drug substance or key intermediates
• Develop process understanding, including identification of CPPs, CQAs, and appropriate control strategies
• Support scale-up activities from lab to pilot and commercial manufacturing, including tech transfer to CDMOs or internal sites
• Author and review technical reports and CMC documentation to support IND, NDA, and lifecycle submissions (CTD Module 3.2.S / 3.2.P as applicable)
• Collaborate with Analytical Development to define appropriate in-process controls, specifications, and method requirements
• Lead or support investigations (deviations, OOS/OOT) and implement effective, science-based corrective actions
• Evaluate raw materials and starting materials, including vendor qualification and risk assessment
• Contribute to process validation strategy, including PPQ planning and continued process verification
• Provide on-site support at manufacturing facilities during key activities (e.g., scale-up, engineering runs, PPQ) as needed
• Work effectively in a cross-functional team to align development, manufacturing, and regulatory expectations
  
  

What It Takes

The role requires strong scientific and technical judgment to translate early process concepts into scalable, manufacturable systems. The Scientist II must balance experimental design, data interpretation, and cross-functional alignment while making decisions under uncertainty and prioritizing work based on program needs.

What You Bring

• Ph.D. in Chemistry, Chemical Engineering, or related field with 3 years of relevant industry experience OR M.S. with 6 years / B.S. with 8 years of relevant experience
• Strong background in small molecule process development, polymer/organic chemistry, or complex material systems (experience with hyaluronic acid or biomaterials is a plus)
• Experience in process scale-up and technology transfer to GMP manufacturing
• Working knowledge of CMC regulatory expectations (ICH Q8, Q9, Q11; CTD Module 3)
• Hands-on experience with typical analytical tools (e.g., HPLC, LC-MS, NMR) and ability to interpret data to guide decisions
• Experience supporting late-stage development and/or commercial manufacturing is preferred
  
  

Nice to Have

• Solid problem-solving skills with a focus on practical, scalable solutions
• Ability to make decisions under uncertainty and prioritize work based on program needs
• Strong communication skills, with the ability to clearly explain technical concepts to cross-functional teams
• Collaborative mindset; works effectively with internal teams and external partners
• Attention to detail while maintaining awareness of the broader program goals
  
  

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.