Merck

The Oral Formulation Sciences (OFS) team is responsible for the research and development of oral products for a range of modalities including small molecules and peptides.. Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles include the design and development of formulation, manufacturing processes, and packaging to enable phase-appropriate regulatory filings for oral products.. Will be responsible for functional strategic planning, coordinating, and execution of OFS initiatives for the compan portfolio from discovery to launch.. Relevant experience in Oral Product Development with an understanding of all stages and aspects of development, with experience in design of oral drug product compositions and processes, GMP manufacturing considerations and scale-up/tech transfer activities. Demonstrated experience solving program challenges by leveraging a breadth of experiences, including oral product development, pharmaceutical operations, commercialization and scientific organic and physical chemistry, analytical chemistry, biopharmaceutics, material science, process development, and/or engineering and regulatory science.

formulation

Job Description
Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover and develop the next medical breakthrough. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing, and scaling up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting-edge science to transform drug delivery and manufacturing technology to positively impact patients.
The Oral Formulation Sciences (OFS) team is responsible for the research and development of oral products for a range of modalities including small molecules and peptides. Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles include the design and development of formulation, manufacturing processes, and packaging to enable phase-appropriate regulatory filings for oral products. This research-based team contributes to Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverables, which is the development of robust compositions and processes that enable patient-centric products for patients. The successful candidate:
Should have a vision to develop a team, demonstrated leadership skills, demonstrated mentorship skills, oral product technical & domain expertise, effective communication skills, understanding of the regulatory environment, and vision to influence the regulatory environment.
Will be responsible for functional strategic planning, coordinating, and execution of OFS initiatives for the compan portfolio from discovery to launch.
Will need to collaborate in a multidisciplinary team environment with key stakeholders across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC, and technical functions, to ensure timebound progression of portfolio, initiatives for scientific & operational excellence and other strategic goals that advance functional impact.
In this role, the person will be responsible for driving a portfolio of oral development programs, while developing new ways of working to meet timeline requirements. This includes direct collaboration and coaching team members to collaborate with multiple stakeholders across both our Research Division and our Manufacturing Divi in the design of new formulations and the development of robust and scalable processes for commercial products. Advancing a culture of continuous learning and improvement, scientific and operational excellence, safety, GMP and compliance mindset, and collaboration with various partners and stakeholders in development is expected.
The Director will report to the Executive Director of Oral Formulation Sciences and will have approximately 10-15 direct reports composed of experienced, senior and associate scientists. The successful candidate will work with the OFS leadership and extended leadership teams to implement strategy, conduct scientific research from the laboratory to commercial scale, step across boundaries, and implement novel innovations during drug product development to enable the best science at first filing for oral development processes for human health while ensuring a phase appropriate approach during early development.
In this role, the person will be responsible for the recruiting, appraisal, and development of staff under her/his supervision, guiding individuals to reach their full potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary. The candidate will also have a proven track record of developing talent from a diverse scientific background and will have the ability to advance our company's commitment to a diverse and inclusive work environment.
Knowledge, Duties & Responsibilities for the Director Include:
Oral drug product development concepts, tools, and requirements for all dosage forms
Work as a sponsor with program and formulation leads to establish a scientifically-driven and staged-based approach to program development.
Ability to recruit, select, develop, and mentor talent.
Strategic and critical thinking to advance OFS programs and strategy
Project management skills
Builds collaborations across internal company departments and key stakeholders.
Ability to lead and champion organizational structure and be a change agent when necessary.
Communicates effectively and builds strong relationships with upper management and other disciplines to drive enterprise decisions.
May serve as a program lead on programs that carry significant technical and/or operational complexity related to drug product development.
Qualifications
Education
Ph.D. with +7 years or B.S/M.S. with +10 years in pharmaceutical sciences, chemistry, chemical / biochemical engineering, or related disciplines.
Required
Effective communication skills
Effective leadership skills and a motivation to work in a diverse team environment.
Collaborates effectively within and across functional areas.
Experience mentoring and developing scientific staff.
Effective strategic, operational and technical problem-solving abilities
Relevant experience in Oral Product Development with an understanding of all stages and aspects of development, with experience in design of oral drug product compositions and processes, GMP manufacturing considerations and scale-up/tech transfer activities
Demonstrated experience solving program challenges by leveraging a breadth of experiences, including oral product development, pharmaceutical operations, commercialization and scientific organic and physical chemistry, analytical chemistry, biopharmaceutics, material science, process development, and/or engineering and regulatory science.
Proven ability to lead program development teams using project management skills.
Preferred Experience and Skills
Knowledgeable of the Capital Process having participated on a large capital project team.
Experience in regulatory compliance expectations across all phases of product development to commercialization.
Demonstrated leadership skills and organization design (i.e. building high performing teams, building talent, and shown to be able to motivate, influence scientific team; lead by example through past scientific / technical expertise).
Supports innovative thinking / risk-taking and eliminates obstacles / barriers to implement change.
Ability to present clear and compelling quality and business cases. Ability to engage and align other stakeholders outside the project team.
Ability to apply and promote a growth mindset with teams and partnerships.
#EligibleforERP
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Expected salary range:
$164,800.00 - $259,400.00
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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Employee Status:
Regular
Relocation:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a

Requisition ID:R282910

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