Mfg Operations Associate Director - Biologics, Drug Substance
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Job Description General Summary: The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners. This role is responsibl…
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Mfg Operations Associate Director - Biologics, Drug Substance
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$160k–$240k/yr
Full-time
bachelor degree, postgraduate degree
Annual Bonus, Annual Equity Awards, Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off
Posted 30d ago
~40 hrs/week
Responsibilities
Accountable for the technical execution of biologics drug substance manufacturing at external partners to ensure reliable supply and process consistency. Serves as the senior technical leader for manufacturing execution, driving performance, standardization, and rapid issue resolution across CDMOs.
Requirements
Requires a bachelor's degree in biological sciences or engineering and over 10 years of experience in biologics manufacturing or MSAT. Must have demonstrated expertise in cGMP environments, deviation management, and leading technical teams within external manufacturing operations.
Full job description
Job Description
General Summary:
The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners.
This role is responsible for ensuring processes are executed as intended and delivering reliable supply. The Associate Director serves as the technical leader for manufacturing execution, driving performance, standardization, and rapid issue resolution across programs and CDMOs.
The Associate Director, Technical Services role is a key member of Vertex’s External Manufacturing Organization (ExM), providing support, strategic insights and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO).
The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners. This role is responsible for ensuring processes are executed as intended and delivering reliable supply. The Associate Director serves as the technical leader for manufacturing execution, driving performance, standardization, and rapid issue resolution across programs and CDMOs.
Key Duties and Responsibilities:
Provide technical leadership for drug substance manufacturing campaigns at external partners, serving as the senior technical decision-maker during active operations to ensure consistent, compliant, on-time execution and strong campaign readiness
Oversee triage, resolution, and documentation of execution-related deviations, ensuring rapid containment to protect product quality and supply
Lead cross-functional coordination across MSAT, Quality, and manufacturing teams, escalating and framing complex issues as needed
Own process operability and execution robustness at the manufacturing site, including batch record clarity and usability
Drive improvements in yield, cycle time, right-first-time performance, and overall manufacturing reliability
Lead campaign readiness, including implementation of CAPAs and process updates
Serve as the senior technical interface during manufacturing operations, providing day-to-day guidance and driving communication, responsiveness, and accountability at the site level during campaigns
Oversee real-time monitoring of batch and campaign performance, identifying risks, process drift, or execution gaps and drive timely technical interventions as needed to maintain schedule adherence, quality, and supply reliability
Escalate complex or non-routine issues requiring deeper process understanding to MSAT, ensuring clear technical framing and efficient handoff
Oversee implementation of approved process and operational changes, ensuring effective execution and expected performance outcomes
Build and strengthen Technical Services capability within biologics, including defining ways of working and developing technical staff
Drive a culture of accountability, urgency, and operational rigor
Knowledge and Skills:
Deep understanding of biologics drug substance manufacturing processes and cGMP operations
Strong experience with real-time manufacturing support, including batch execution, deviation management, and troubleshooting
Ability to identify and resolve technical issues quickly in a live manufacturing environment
Working knowledge of batch records, investigations, change control, and quality systems
Proven ability to operate effectively in a matrixed environment, coordinating across MSAT, Quality, and manufacturing teams
Strong communication skills with the ability to drive clear decisions under time-sensitive conditions
Demonstrated focus on execution, accountability, and operational rigor
Strong technical background in aseptic manufacturing operations.
Solid project management skills and experience managing complex projects.
Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
Strong leadership and an innate ability to collaborate and build relationships is critical.
Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
Flexibility to work shift hours required to cover critical process steps
Ability to travel, national and international, up to 30%
Education and Experience:
BS/BA degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline; advanced degree preferred
Requires 10+ years of experience in biologics manufacturing, MSAT, or external manufacturing
Demonstrated experience supporting or leading manufacturing execution at a site or external partner
Experience with deviation management, investigations, and real-time technical troubleshooting in a cGMP environment
Prior experience working with external manufacturing partners strongly preferred
Previous leadership experience, including leading technical teams or cross-functional initiatives, preferred
Requires progressive experience in a management/leadership role in the biotechnology/ pharmaceutical industry with a focus on external manufacturing and commercial operations
Excellent communication and interpersonal skills, with the ability to influence cross-functional stakeholders and present insights to all levels of senior stakeholders
Demonstrated continuous improvement mindset, driving efficiencies, process improvements across diverse initiative
Pay Range:
$160,000 - $240,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
Together we deliver connected solutions to conquer tax complexity.
Industry
Software Development
Company size
1,001-5,000 employees
Headquarters
King of Prussia, PA
LinkedIn followers
69,034
Total funding
$345M
The rapid changes taking place in today’s global business, technology, and regulatory environments are having a compounding effect on the complexity of indirect tax management and putting more pressure on the corporate tax function than ever before. This complexity demands intelligent solutions that enable businesses to satisfy tax obligations and support growth opportunities.
The Trusted Leader in Tax Technology
We're Vertex (VERX). A pioneer in tax automation for more than 40 years. We proudly serve over 4,000 customers worldwide with distinction and provide comprehensive tax solutions that enable global businesses to transact, comply and grow with confidence.
Our software, content and services address the increasing complexities of global commerce and compliance by reducing friction, enhancing transparency and enabling greater confidence in meeting indirect tax obligations. As a result, our software is ubiquitous within our customers’ business systems, touching nearly every line item of every transaction that an enterprise can conduct. Our software is fueled by over 300 million data-driven effective tax rules and supports indirect tax compliance in more than 19,000 jurisdictions worldwide.
We partner with the world’s most respected companies and harness their strengths to deliver the best tax technology solution to businesses across the globe. We integrate with key technology partners that span ERP, CRM, procurement, billing, POS and e-commerce platforms. We also work closely with over 50 tax, accounting and consulting firms to provide the integrated tax technology solutions.
Our culture is the foundation of everything we do, guided by a common purpose to build trusted relationships at work, in business and in our communities. We strive to be a values-driven employer of choice who attracts, retains and inspires talented professionals to achieve their full potential. We employ over 1,100 full-time professionals today in the US, Europe and Brazil.
Offices: 2301 Renaissance Blvd, King of Prussia, PA 19406, US · 40 Shuman Blvd., Suite 218, Naperville, IL 60540, US · 1 Furzeground Way, Stockley Park, Stockley Park, Uxbridge UB11 1EZ, GB · 101 Arthur Andersen Parkway, Suite 300, Sarasota, FL 34232, US · Gustav Mahlerplein, Amsterdam, North Holland 1082, NL
taxtransaction taxindirect taxtax compliancesoftwareVATvalue added taxsales and usemanaged servicesreturns outsourcing
Based on 2130 listings with disclosed salaries, most healthcare jobs in Washington pay between $80k–$189k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Washington right now?
There are currently 11,642 open healthcare positions in Washington listed on Clera. New openings are added daily as companies post roles.
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Companies currently hiring include MultiCare Health System, PROVIDENCE MEDICAL INSTITUTE, UW Medicine, Virginia Mason Franciscan Health, Agape In Home Care, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Washington?
Yes — 970 of the 11642 open healthcare positions offer remote or hybrid work (315 remote, 655 hybrid).
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