Skip to main content

This job has expired

Senior Director, Analytical Process Development

Employer
University of Massachusetts Medical School
Location
460 Walk Hill Street

View more

Employment Type
Full Time
Institution Type
Four-Year Institution
Send job

Job Details

Overview

 

POSITION SUMMARY: 

The Senior Director of Process Development is responsible for overseeing process development and technology transfer to product manufacturing according to Food and Drug Administration (FDA) guidelines and current Good Manufacturing Practices (cGMP). The Senior Director will assist in development of departmental strategic plans and prioritize projects with an emphasis on continuous production and quality improvements. This is a performance based position where success is measured through the achievement of organizational and departmental goals.

Responsibilities

ESSENTIAL FUNCTIONS:

  • Plans and manages departmental strategy to meet organizational and departmental objectives as well as Process Development related regulatory commitments. Ensures timely delivery on key milestones.
  • Oversee the development, design and scale-up processes, instruments and equipment used to perform the process development and manufacturing functions.
  • Oversee and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals.
  • Oversee the optimization of production of products manufacturing, assuring compliance with GMP and FDA regulations.
  • Oversees analytical testing to support process development and manufacturing where appropriate.
  • Oversee technology and manufacturing process transfer, providing product for applicable clinical trials as required.
  • Provide leadership and direction imperative for the successful growth and operations within this Process Development. Department and relationships with internal and external development efforts. Oversee the development of efficient cell culture processes.
  • Plan and manage strategy for process design, optimization, scale-up, technology transfer and process troubleshooting to meet project timelines and company goals.
  • Provide scientific and technical leadership for pre-clinical projects and projects in clinical development and technical support for commercial product.
  • Responsible to allocate resources and budget to ensure successful achievement of departmental goals. Provides Process Development input to organizational budget.
  • Identifies, develops, and as required, validates new technologies and methods to improve Process Development and Manufacturing operations.
  • Ensures that all necessary documentation is maintained. Reviews and approves departmental reports. Ensures the integrity of Process Development's contributions to regulatory submissions and due diligence documentation.
  • Communicates key issues, and interfaces effectively at all levels within the organization including participation at regular senior management meetings to include pertinent input on scientific, technical and compliance issues to other groups as required.
  • Represents Process Development in discussions with corporate partners in the US and overseas and with the FDA as appropriate.
  • Maintains current knowledge of new technologies and innovations within the field of MAb cell culture, purification and formulation.
  • Hires, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance.
  • Collaborates with Manufacturing and Manufacturing Technical Services to support the implementation of cost effective production procedures that will improve product quality and yield.
  • Perform additional job related duties as required.
Qualifications

REQUIRED QUALIFICATIONS:

  • Requires a PhD and demonstrated senior leadership experience. Alternatively, Bachelor’s degree and 12 years’ experience including senior management experience.
  • Relevant experience and technical knowledge in biologics process development is required.
  • Demonstration of initiative and leadership through experience.
  • Demonstrated ability to interact with senior management and regulatory officials.
  • Clear, concise, written and verbal communication and presentation skills.
  • Ability to maintain extensive working knowledge and proficiency in applicable cGMP regulations and procedures.
  • Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought.
  • Strong organizational skills demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required.
  • Ability to manage performance and motivate personnel to work effectively and efficiently.
  • Position may require travel.
  • Requires ability to work extended, and at times, unusual hours, to meet business needs.

 

PREFERRED QUALIFICATIONS:

 

  • Experience with monoclonal antibody production preferred.
  • Prior experience with upstream and/or downstream process development and technology transfer for cGMP biologics manufacturing preferred.
Additional Information

#LI-AT1

Organization

Realize Your Opportunities – A Career at UMASS Medical School

Inside Workings at UMASS Medical School

The University of Massachusetts Medical School (UMMS), the Commonwealth's only public medical school, is proud of our role in serving the people of Massachusetts. Although, its the inside workings of UMMS that makes the difference.

Mission and Culture

  • We’re serious about our mission and about our people. 
  • Real World Impact - Our people get excited about our mission of real-world impact in health sciences education, research and public service.
  • International Prominence and New Opportunities - As this institution has grown to national – and international – prominence, we’ve found new opportunities to train tomorrow’s physicians, nurses and scientists,  discover causes of and cures for disease and help improve the quality of health care.
  • Deep Commitment - With our clinical partner, UMass Memorial Health Care, and our other teaching affiliates, we share a deep commitment to national distinction in patient care.
  • Valued Partnerships – UMMS partners with Commonwealth Medicine, the health care consulting arm of UMMS. Also, UMMS partners with MassBiologics in scientific collaborations, technology management and creating partnerships for the development of products for the benefit of patients.  These valued partnerships help us to provide services and programs to help meet our needs at UMMS and the public.
  • Proud Contributors - People at UMMS enjoy the feeling of going to work every day knowing what they do is truly important and worthwhile.
  • Complementary and Inseparable - These varied parts of our mission and culture are complementary and inseparable.                 

Careers

UMMS, the state’s first and only public academic health sciences center, educates physicians, scientists and advanced practice nurses to heal, discover, teach and care, with compassion.  UMMS is a world-class institution with opportunities to match. 

Competitive Compensation – UMMS offers salaries that are competitive with Worcester-area employers. When combined with our generous benefits, perks, and paid time off, many job seekers are surprised to find a total rewards package that matches or exceeds their current situation.

Targeted Hiring Process – At UMMS, there are actually multiple hiring processes for different segments of our workforce.  In nearly all cases, UMMS hiring process is decentralized, with qualified candidates screened and referred to an academic officer or manager with hiring authority.

24/7 Access to Employment Opportunities – iCIMS is our online job search and application system.  iCIMS is available 24/7 to provide you with a convenient and up-to-date view of the available employment opportunities across our campuses. Updates are made daily and include all faculty and non-faculty position listings from every school and department within the UMMS. When you identify a position you are interested in and qualified for, apply online. New opportunities become available frequently so it pays to check back often!

Benefits

With outstanding benefits, competitive pay, extensive learning opportunities, and a stimulating and attractive work environment, UMMS may be exactly the employer you’ve been looking for.

• Superior Benefits - UMMS offers a wide range of benefits and perks that invite comparison with the best employers in the Worcester area – and with academic institutions anywhere. UMMS provides superior medical and dental coverage for you and your family, fully funded retirement plans, generous time off, a Tuition Assistance Plan – and much more.

• People Centered - UMMS is an employer, but it is also a community. Its comprehensive medical and dental benefits, retirement plans, and even paid holidays reflect an institution built around people, with a deep respect for their differences and needs.

• Commitment to Healthy Living - UMMS provides resources to help you balance work and life and encourages healthy living through great programs and discounts for fitness, physical activity, weight management, nutritional counseling and general wellness available through our health insurance plans.

• Breadth of Offerings - Above all, the breadth of UMMS offerings set the School apart and makes it an environment favored by all sorts of smart, career-savvy people.

Apply for a Job

As an equal opportunity and affirmative action employer, UMMS recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds.

Online - To view all job opportunities and apply online, visit www.umassmed.edu/hr and click on the “Careers” tab.

Start Now and Realize Your Opportunities!

A History of Making Vital Improvements - UMASS Medical School Milestones

1962: Legislation establishes University of Massachusetts Medical School
1970: First medical students begin classes in Shaw Building
1974: First class graduates 16 MDs
1979: PhD program begins
1986: Graduate School of Nursing opens
1986: PhD program becomes Graduate School of Biomedical Sciences
1994: Graduate School of Nursing initiates PhD program
1998: UMass Clinical System and Memorial Health Care merge to form UMass Memorial Health Care
2001: Lazare Research Building opens
2002: Campus Modernization begins on the University Campus
2004: Graduate Entry Pathway Program established at the Graduate School of Nursing
2005: PhD Program in Clinical & Population Health Research established at the Graduate School of Biomedical Sciences
2005: Massachusetts Biologic Laboratories opens new manufacturing and filling facility in Mattapan
2006: Craig Mello, PhD, Blais University Chair in Molecular Medicine and Howard Hughes Medical Institute Investigator, is awarded the Medical School's first Nobel Prize. Dr. Mello shared the 2006 Nobel Prize in Physiology or Medicine with Andrew Fire, PhD, of Stanford University, for their discoveries related to RNA interference.
2007: Michael F. Collins, MD, is named chancellor and Terence R. Flotte, MD, is named dean of the School of Medicine.  
2009: Groundbreaking for the Albert Sherman Center, a 500,000-square-foot research and education facility slated for completion in 2012.
2010: Ambulatory Care Center opens
2012: The Albert Sherman Center, a 500,000-square-foot research and education facility, completed and opens

Send job

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert