Merck is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. Today, we are building a new kind of healthcare company – one that is ready
to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team,
you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
This position is responsible for providing in-depth scientific and technical expertise within the Analytical Science functions in Analytical Development and Commercialization for Puerto Rico Pharmaceutical Operations, in support of late stage development and launch of new drug products as well as in-line product investigations. This position will provide the opportunity to work and collaborate with engineers, scientists and other partners in cross-functional and/or multi-site teams.
Location: Merck Las Piedras, Puerto Rico
* Develop, validate, document and transfer on-line, in-line and at-line physical and chemical characterization methods for the analysis of developmental, clinical and final drug product materials (solid oral dosage forms).
* Conduct or lead analytical testing of developmental or clinical materials, including the approval of clinical testing results.
* Support and troubleshoot drug product projects during late stage development and launch at the Las Piedras site (other sites as necessary), including collaboration and partnering with process engineers in designing process characterization and robustness studies.
* Conduct and/or lead activities and manage projects of increased complexity and scope on product and analytical development/transfer, registration, stability and special studies.
* Identify, design and perform experiments and provide solutions to analytical challenges and other laboratory related issues.
* Evaluate and interpret lab study results and communicate to management, site and cross-functional project teams.
* Lead and support initiatives with the goal of increasing lab safety, compliance and efficiency, with particular emphasis on skill development, coaching and mentoring.
* Maintain up to date knowledge of developments in analytical methodologies including chromatography and, where appropriate, adopt in Las Piedras.
* Maintain up to date training of cGMPs, USP, JP, Ph.Eur , ICH guidelines and regulatory trends, and where appropriate, adopt in Las Piedras.
* Lead, prepare or review analytical CMC sections for regulatory filings, Health Autorithies responses, study protocol and product specifications
This position has no supervisory responsibilities.
* M.S. or Ph.D. in Analytical Chemistry or related area.
* A minimum of 7 years for Ph.D. and 11 years for M.S. in analytical or product development.
* A minimum of 4 years in analytical method development, including chromatography, in a pharmaceutical development setting.
* Experience with dissolution method, physical characterization methods, QbD and specification setting is desirable.
Other requirements include:
* In depth scientific understanding of analytical methodology.
* Hands on experience with analytical instrumentation and troubleshooting.
* Working knowledge of drug substance and/or drug product expiry assignment.
* Working knowledge of GMPs and ICH and/or other quality guidelines.
* Knowledge of Statistics and design of experiments (DOE).
* Knowledge of pharmaceutical formulations and/or pharmaceutical manufacturing and/or pharmaceutical process development.
* Experience with preparation of sections for IND and/or IND amendments and/or WMA/NDA submissions.
* Bilingual (Spanish and English, in oral and wrtitten).
* Other Skills: Strong communication, leadership, collaboration and project management; demonstrated problem solving; coaching, mentoring and influencing.
* Experience working with cross-functional teams.
* Computer literate (MS Word, Excel, Access, Power Point, etc.)
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs
and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job Title:Assoc Prin. Scientist, Chemistry
Primary Location: NA-Puerto Rico
Other Locations: NA-PR-East-Las Piedras
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): N/A