Senior Specialist, Manufacturing Automation (On-site) - Military Veterans
at Merck & Company
Job Description
The Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep structural understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch and into supply for extended characterization methods.
The Structure Characterization team provides modality agonistic characterization to solve urgent questions arising across the entire pipeline through conformational dynamics and structure elucidation, as well as delivery of structure and quantification of molecules, intermediates, and degradation products to identify potential CQAs. The team also establishes structural understanding through high resolution Mass Spectrometry and NMR characterization across modalities to build mechanistic understanding to enable insights in structure-function and molecular interactions with excipients.
The Executive Director reports to the Associate Vice President, Analytical Enabling Capabilities and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-60 people across our Boston, MA, Rahway, NJ, South San Francisco, CA, and West Point, PA sites. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from discovery into supply.
The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. The Executive Director would be accountable for the growth/career development and performance of their team with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team, and implement and manage change to enable process improvement and optimal workflows.
Responsibilities include, but are not limited to, the following:
- Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Enabling Capabilities with delivery of high-resolution Mass Spectrometry and NMR characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel methodology and processes to position Analytical Enabling Capabilities to deliver against future pipeline needs.
- Quality and Regulatory Standards: Develops and implements phase appropriate methods for structure and quantification of molecules, intermediates, and degradation products when required. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
- Project Management and Teamwork: Responsible for managing quality and timelines for development projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a partner with collaborators and teams.
- Building Teams & Talent: Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives.
- Communications: Maintains productive communications with staff, colleagues across Discovery and CMC development as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs.
Education:
- MS in relevant scientific discipline with 15+ years' experience or PhD in relevant scientific discipline with 12+ years' experience
Required Experience and Skills:
- 12 + years of biopharmaceutical development experience.
- Subject matter expertise in structure elucidation.
- Demonstrated ability in leading large teams and mentoring and developing talent.
- Incumbent must have excellent interpersonal, communication, and collaboration skills.
- Strength in delivering results on firm deadlines in support of drug/vaccine development.
Preferred Experience and Skills:
- Broad external network with experience advancing the field of enhanced structure elucidation capabilities.
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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Under New York State, 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:
$243,500.00 - $383,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .
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:
Regular
Relocation:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
08/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
New York, NY
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Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.