Associate Specialist Operations

Job Description

The Small Scale Organics (SSO) Pilot Plant is a GMP manufacturing facility in the Small Molecule Process Research and Development (SMPR&D) organization. The pilot plant’s mission is to serve as the preferred site for the first demonstration of small molecule manufacturing processes, methods & technologies, as well as SMPR&D’s internal node for small molecule drug substance clinical manufacture. This mission enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless technology transfer to commercial sites.

The SSO Operations Specialist will provide hands on assistance for daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements to meet SSO objectives and customer requirements. The position is responsible for implementing actions to meet S&E and GMP requirements. This position is also responsible for ensuring facility readiness for API processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building, and ultimately strong support for the overall SMPR&D pipeline.

Responsibilities:

• Under the scientific direction of a team lead, the Operations Specialist will participate in the planning and execution of equipment setups and batch processing at a pilot scale, capture process knowledge, and troubleshoot equipment with the aim advancing process development, aiding technology development and supplying API for clinical use and drug product development. This will involve handling of a variety of reagents, solvents and active pharmaceutical ingredients during “wet chemistry” operations (performing chemical reactions, crystallizations, distillations, etc.) as well as dry powder processing (e.g., dry milling).

• Ensure processes are run within the capability constraints of the facility.

• Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and consumable inventory.

• Provide input for incident root cause analysis, reporting, and action items.

• Facilitate and drive building improvement projects and corrective/preventative action closures.

• Provide input on process setups.

• Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset.

• Collaborate with all building staff to share and align on best practices.

• Actively investigate problem statements and safety observation reports (SORs) to promote fast and efficient closure.

• Understand High Risk Work.

• Identify opportunities to improve building flexibility, efficiency, compliance, and safety.

• Author lessons learnt and summary reports to capture knowledge

Education Minimum Requirement:

• Associate’s or Bachelor's degree in a relevant technical field.

Required Experience and Skills:

• Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.

• A strong mechanical aptitude.

• Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.

Preferred Experience and Skills:

• Understanding of/Experience with process scale-up of chemical processes, moving from the laboratory to the pilot scale.

• Lean Six Sigma Training / Certification.

• Operations experience.

• Familiarity with the administration of Current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental regulations as it pertains to pharmaceutical development.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R198731