Director, Engineering

Job DescriptionJob Description:Our Small Molecule Science & Technology – End to End Technical Product Leadership team is looking for a Director to lead the existing Global Technical Change Control Center of Excellence which comprises a team of approximately 15 with inclusion of People Leaders, Individual Contributors, and contractors. This organization focuses on stewarding the end to end Change Control process for our External Partners, Global and Strategic Alliances, External Suppliers of Incoming Materials and Analytical Change Control. Likewise, we are looking for this organization to enhance their role in partnering with Development and Commercialization Teams (DCTs) to establish the change control strategy to enable the lifecycle of the product as it flows from commercialization thru to supply. Interested candidates must be capable of providing boundary-less application of leadership skills for project management and global change management while staying aligned with changing requirements and continuously identifying and improving the support to our customers.Responsibilities include but are not limited to the following:

Leading, managing and developing a team responsible for providing change control processing and stewardship to external network (supporting all areas of External Manufacturing including Chem/API, Drug Product, Packaging, Medical Devices and Combination Products, Sterile and Biologics), small molecule technical supplier change controls that impact multiple site/products and change control portals for Global Alliances

Leading a Change Control Center of Excellence focused on sharing best practices and increasing efficiencies managing change control in the Pharmaceutical Technical Operations space while ensuring compliance

Capable of driving transformational change in the global change control space, applying deep knowledge gained across multiple areas of the company, and ensuring sustainability by using a Change Execution Methodology mindset

Compiling change control metrics for Management Review Meetings

Providing input and/or supporting change control business improvement initiatives

Ensures training requirements and roles and responsibilities are clearly understood and followed

Provides customer service support to DCTs and Sites for questions related to change control requests and the change control process

Participating and/or leading, as needed, continuous improvement of the change control business processes related to External manufacturing, Suppliers and/or Alliance Partners

Owning the product numbering process for our Company.

The ideal candidate for this role will demonstrate the following behaviors and attitudes:

Strong leadership skills with experience leading individuals and teams through change and new challenges

Self-starter who is comfortable working in and leading a team through ambiguity

Enterprise mindset with keen understanding of the end-to-end eco-system impacting our small molecule products.

Demonstrated project management of cross functional/divisional activities

Strong collaboration skills

Required Education, Experience and Skills:

A Bachelor's degree in Science or Engineering and at least twelve (12) years of experience in Pharmaceutical/Biotech Manufacturing or Manufacturing support OR

A Master's degree in Science or Engineering and at least ten (10) years of experience in Pharmaceutical/Biotech Manufacturing or Manufacturing support OR

A PhD in Science or Engineering and at least eight (8) years of experience in Pharmaceutical/Biotech Manufacturing or Manufacturing support

People Management experience.

Demonstrated interpersonal skills including flexibility and ability to work in a team environment

Proven analytical capabilities and demonstrated written and verbal communication skills

Ability/willingness to travel up to 20% to support customers and/or meet with team

Preferred Experience and Skills:

Strong technical/manufacturing background in pharmaceutical and/or packaging operations including quality systems and process technology.

Global Change Management (GCM) experience and direct accountability

Lean tools and systems experience

Strong facilitator skills to oversee change control meetings

Excellent organizational and project management skills

Demonstrated ability to take initiative and attention to details

Proven ability to lead and/or manage complex projects across a broad spectrum of activities

Strong interpersonal and leadership skills to participate actively in virtual teams & communicate, collaborate, negotiate & persuade across a broad variety of functions and cultures.

Ability to work independently or in teams.

Experience supporting the External Manufacturing integrated organization

Analysis, assessment and facilitation of recommended improvements of end-to-end Global Change Management process across all platforms in support of External Manufacturing (internal network a plus)

NOTICE FOR INTERNAL APPLICANTSIn 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.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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.Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.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:$164,800.00 - $259,400.00Available 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 (https://www.benefitsatmerck.com/) .Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:25%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:08/20/2024A 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.Job Posting End Date: 08/20/2024A 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.Requisition ID: R307472