Senior Development Chemist

Unither • Rochester, NY

8d • $85,000 - $105,000 • Onsite

About The Position

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible. With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees. Your role Reporting to the Lead Development Chemist, JOB SUMMARY: Performs method validation and development from design to execution independent of supervision. Manages complex, multi-disciplinary projects with minimum input. Implements improvements to lab quality systems. Provides analytical support commercial, and development products and manufacturing. Provides technical resource for QA laboratories. Although this position is a senior level; this position is responsible for assisting and performing day to day laboratory testing and tasks.

Requirements

• Bachelor’s degree in life science or closely related.
• 5-10 years of experience working in analytical laboratory experience with knowledge and/or familiarity with HPLC, GC, GC/LC-MS, FTIR, UV/Vis, SEM, CE, Chiral Separations, dissolution
• 3-5 years in Regulated Industry, Pharm preferred
• Must have previous experience in cGMP environment
• Proven success in method development and validation
• Statistical data evaluation to include experimental design a plus.
• Basic Outlook and PowerPoint skills, Intermediate MS Word and MS Excel skills
• Must demonstrate visual acuity, color recognition, finger dexterity.
• The ability to read, write and communicate in English.
• Sitting approximately 50% of day and standing approximately 50% of day.
• Work responsibilities may involve repetitive use of the hands through keyboarding, simple grasping and fine manipulation.
• Occasional lifting of up to 35 pounds.
• Normal office environment and occasional controlled environment work that may require removal of jewelry and cosmetics.
• Decisions require complex analytical judgment.
• Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities, and including their application to cases not routinely covered.
• Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.

Nice To Haves

• Statistical data evaluation to include experimental design a plus.

Responsibilities

• Conducts incident investigations to determine root cause.
• Assesses product impact.
• Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.
• Coordinates documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation.
• Collaborates with internal groups to determine and implement preventative measures to reduce/eliminate repetitive deviations.
• Identifies, offers, and implements plans to prevent and overcome analytical issues and performs method trouble shooting.
• Provides analytical leadership and consultation internally.
• Serves as analytical lead for customer and government regulatory agency site inspections.
• Coordinates work of lab personnel to support on-time delivery of analytical data to projects.
• Functions as Analytical Representative and SME on project teams.
• Provides consultation regarding new test methods as required.
• Performs analytical method development, validation and project support from design to execution.
• Provides scientifically sound, clearly written analytical data packages/reports suitable for submission.
• Writes protocols and reports.
• Reviews and checks analytical data generated by peers and maintains integrity of data.
• Provides analytical solutions to manufacturing troubleshooting, process development and improvements.
• Evaluates regulatory changes to existing methods: i,e Ph.EU and USP monograph changes.
• At customer request, investigates new technologies and analytical approaches for utilizing existing in-house instrumentation to improve test efficiency/effectiveness.
• Investigates and recommends analytical instrumentation purchases for cost improvements and operational efficiencies.
• Proactively participates in activities in support of process changes.
• Suggests and leads process improvements to refine current systems and improve efficiencies.
• Builds systems that translate training and development needs into appropriate, cost-effective learning and development interventions that support the effectiveness of the individual and the Labs.
• Develops methods to transfer information and techniques from training sessions to actual on-the-job performance.
• Evaluates training effectiveness by using pre-test and post-test measures, interviews, and examining various records and reports; and recommends modifications to training as appropriate.
• Delivers one-on-one or group training to individuals on assigned processes that includes not only information on the process, but the opportunity to practice.
• Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend an appropriate solution to performance problems.

Benefits

• 100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives

What This Job Offers

• Job Type: Full-time
• Career Level: Senior