Job Description

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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 plants mission is to serve as the preferred site for the first demonstration of small molecule manufacturing processes, methods & technologies, as well as SMPR&Ds 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 (reordered). 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

Minimum Education Requirements:

* Associates or Bachelor's degree in a relevant technical field; high school diploma and relevant experience in a process development lab, pilot plant/manufacturing facility, or role demanding mechanical aptitude and computer skills.

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.

* 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.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

solvents and reagents

Number of Openings:

3
Requisition ID:R107984