Merck & Co., Inc.

Director, Biotechnology Solutions

Posted on: 20 Mar 2021

Elkhorn, NE

Job Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Goals

* This position is responsible for managing the Bio Technology and Support (BTS) activities at the Elkhorn, Nebraska site within the Manufacturing Division Animal Health

* Works together with Site Leadership Team to achieve our Company Animal Health (AH) business goals

* Direct reports 5-12 individual contributors

* Responsible for the management and the control of the portfolio of Antigen and Vaccine related technical projects within the Elkhorn AH site

* Provide guidance and direction to the teams to enable reliable Supply and new products commercialization

* Partner with the relevant organization within Elkhorn-AH to define the right priorities for the different projects

Primary Responsibilities

* Responsible for the management and the control of the portfolio of BTS related technical projects within the Elkhorn site

* Final responsibility for the execution of these Large Molecule related technical projects lies with the incumbent

* Interface primarily with the Elkhorn Plant Site Manager and its leadership team

* Clearly define the requested services,

* Follow up the quality and the timeliness of the delivered services,

* Evaluate the future needs and services for upcoming projects on mid-long and long term

* The different activities and projects to be managed are (but are not limited to):

* Providing technology support to production

* Guidance to the local teams to align on strategic priorities and local priorities.

* Gathers voice of customer & voice of business, challenges and converts into action

* Process Transfer management of antigen and vaccine changes (from R&D to Site, from Site to Site,)

* Process robustness improvements to increase revenue (e.g. yield improvements, improved line utilization)

* Supports investment requests/processes

* Providing support and enables connection to other Bio Technology Support teams globally

* Support Regulatory Affairs to review Manufacturing Outline (Drug Master File/Master Manufacturing Instructions) and GCMs (Global Change Management)

* Responsible for workforce planning and talent development for the Elkhorn BTS team, taking into consideration technical gaps and needs for the future

* Sponsor the team in problem solving activities using the Company Production System (CPS) tools and Sigma to ensure the direction and control of continuous improvement, waste reduction and yield improvement

* Manage own competing timelines and prioritize critical tasks

* Transfer (implement) technologies to agreed schedules, milestones and objectives, and cost

* Ensure compliance with corporate and regulatory requirements

* Assure area activities comply with our Company policies, EHS, governmental regulations, etc. and that all expectations are clearly defined and communicated

Education Minimum Requirements

* Bachelor degree with minimum ten (10) years of experience in manufacturing within the health care industry

* Preferred: Masters degree with a minimum eight (8) years of experience in manufacturing within the health care industry OR a PhD with a minimum five (5) years experience in manufacturing within the health care industry

Required Experience and Skills

* Vaccine/large molecule development or manufacturing

* minimum (3) years in a leadership role

* Proven track record of managing project portfolios in the areas of development/commercialization/tech transfer

* Proven track record of talent development

* Strategic and effective in leading and influencing cross functional teams

* Strong analytical and problem-solving skills

* Understanding Regulatory/Compliance requirements

* Demonstrated ability to communicate effectively with multiple teams and levels within the organization

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:

International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Job Sharing

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R95785

Merck & Co., Inc.

Kenilworth, NJ

Merck & Co., Inc. provides healthcare solutions worldwide. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services, and Alliances. The company offers therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, chronic hepatitis C virus, HIV-1 infection, intra-abdominal, fungal infection, insomnia, and inflammatory diseases. It also provides neuromuscular blocking agents; cholesterol modifying medicines; and anti-bacterial and vaginal contraceptive products.

In addition, the company offers products to prevent chemotherapy-induced and post-operative nausea and vomiting; treat non-small-cell lung, ovarian and breast, thyroid, and cervical cancer, as well as brain tumors; and prevent diseases caused by human papillomavirus, as well as offers vaccines for measles, mumps, rubella, varicella, shingles, rotavirus gastroenteritis, and pneumococcal diseases.

Further, it provides antibiotic and anti-inflammatory drugs to treat infectious and respiratory diseases, fertility disorders, and pneumonia in cattle, bovine, and swine; vaccines for poultry; parasiticide for sea lice in salmon; and antibiotics and vaccines for fishes. Additionally, the company offers companion animal products, such as ointments; diabetes mellitus treatment and anthelmintic products; products to treat fleas and ticks in dogs and cats; fertility management products for horses; vaccines for dogs, cats, and horses; and products for protection against bites from fleas, ticks, mosquitoes, and sandflies.

It has collaborations with AstraZeneca PLC; Bayer AG; Eisai Co., Ltd.; and Intec Pharma Ltd. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, distributors, veterinarians, animal producers, and managed health care providers. Merck & Co., Inc. was founded in 1891 and is headquartered in Kenilworth, New Jersey.

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