Principal 1, Organic Synthesis Chemistry

About the role

The Principal I, Organic Synthesis Chemistry supports Alcon's drug substance development activities from early Ideation up through Technology Transfer and Process Validation. Synthetic pathways are assessed/selected to supply drug substance for clinical and pre-clinical toxicology studies. With a view toward launch, the syntheses are developed into practical/viable routes of manufacture using principles of Quality by Design (QbD).

Responsibilities

• Designs and experimentally evaluate synthetic routes for manufacture of drug candidates.
• Conceives/proposes and develops new synthetic routes or methodologies.
• Conducts internal and external brainstorms, evaluates and prioritizes synthetic routes.
• Experimentally evaluates and proposes the final route of manufacture.
• Leverages expertise in drug design, synthesis, and ADME/PK/pharmacology to provide support for ongoing and new ideation projects.
• Carries out scale-up activities to supply early pre-clinical toxicology studies and/or to achieve proof of concept for manufacturing routes and processes.
• Develops robust manufacturing processes using QbD principles which may include: reaction screening/profiling, confirming NOR and PAR and design of experiments (DoE), impurity fate mapping, spiking & purging, process robustness studies, and FMEAs.
• Understands the importance of different crystal forms and develops chemical processes with high polymorph control.
• Carry out technical transfer of chemical processes to contract manufacturing organizations (CMOs).
• Assists with process development, risk assessments (FMEAs), optimization, qualification, and validation of API manufacturing operations.
• Provides support for chemical process development and manufacturing activities at contract research and manufacturing vendors involved in the manufacture of starting materials, key raw materials, and APIs.
• Addresses issues effectively and chooses an appropriate course of action/technique to obtain best results.
• Translate manufacturing instructions and process development data into approvable regulatory process submissions.
• Author SOPs and documents for regulatory submission.
• Maintains good laboratory records and summarizes results in well written reports and oral presentations.

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of Relevant Experience Preferred Qualifications:
• Expert synthetic organic chemist
• Ph.D. in Synthetic/Organic Chemistry with 2-5 years of relevant synthetic chemistry experience (small molecule chemical synthesis/development, pharma preferred)
• Good depth of knowledge/experience with synthetic methodology, chemical literature, and reaction mechanisms
• Hands on experience in process scale up and technology transfer to third party
• Good understanding of process and crystallization control, physical properties, and analysis techniques (XRPD, DSC, TGA, etc.)
• Ability to use/interpret mass spectral data and NMR for the purposes of structure elucidation where required
• Comfortable working in a dynamic, fast-paced environment, interacting with internal and external teams and demonstrates high degree of flexibility
• Enthusiastic and self-motivated with excellent communication (written and oral) and organizational skills
• Experienced working effectively in cross-functional teams
• Working knowledge of GMP, wider CMC activities and regulatory topics including aspects of Quality by Design (QbD), technology transfer, ICH guidance, spiking/purging/specification setting preferred
• Experience with high throughput/data rich experimentation techniques such as DoE
• Strong mechanistic understanding of organic chemistry, and significant process development expertise and awareness of regulatory expectations and development strategies
• Experience with HPLC (Empower a plus)