Associate Director, End-to-End Biodevelopment Lab

Location
Burlington, Massachusetts
Posted
Nov 13, 2018
Ref
183194
Required Education
Bachelors Degree
Position Type
Full time

 

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

Your Role: You will lead the development and non-GMP production of Clinical API for external clients and manage the Process Development teams responsible for all cell culture and downstream processing within the business. You will support the development of new biomanufacturing technologies and solutions through representing Merck BioDevelopment to other internal Merck groups. You will be the technical representative to both internal and external clients that ensure the technical needs of clients are met within the scope of each project with special focus on the technologies and systems used in cell culture and biopharmaceutical purification and analysis in order to facilitate their introduction and application. You will be responsible for maintaining extensive understanding of the quality and regulatory requirements applicable to the field and lead operational and efficiency initiatives within the business operations. You will manage 2 direct reports and support their management of indirect reports by creating appropriate professional and personal development plans for all direct and indirect reports (around 10 employees).

Key Responsibilities:

  • Understanding and experience of GLP (and ideally GMP) aspects for the development of bio-pharmaceuticals. The
  • candidate should also demonstrate good competencies in budget establishment, cost control and optimization.
  • Manage the Development department which includes: upstream services lab unit, upstream and downstream
  • development lab units, in collaboration with the direct manager. This will include as well some analytical activities.
  • Supervise all activities concerning the different step of a process development in line with agreed objectives (described process, timeline and budget) and respecting the requirements of cGLP when needed.
  • Support Production department for process trouble shooting or new equipment implementation when process is
  • transferred.
  • Ensure the compliance of all activities performed in the labs (quality and safety levels).
  • Interface with Sales to enable project sales. Liaises with the larger delivery organization to ensure alignment on
  • process standards and procedures
  • Participates in the strategy definition fort the global delivery organization. Impact on customer and project timelines (First in animal, First in Man and Time to market).
  • Manage the development resources for the USP services, USP and DSP development lab team, in order to ensure:
  • Identification and development of talent and build succession plan within the organization.
  • Correct documentation of the activities in development and services;
  • Permanent inspection readiness through full respect of cGLP, SOPs and WI applicable at the activities;
  • Appropriate training of staff by providing training plan and ensuring right skills developed
  • Feasibility of development planning by managing inter-project activities;
  • Respect Budgets. Participate to the promotion of services in front of clients;
  • Develops and maintain templates for quotes
  • Presents project proposals to clients
  • Manage safety and security of the development units;
  • Participate to continuous improvement and efficiencies programs.

Who You Are:

  • Ideally Masters or PhD level.  Will accept Bachelors with adequate years of relevant experience.
  • 10 + years’ experience in Biotech environment
  • Understanding and experience of GLP aspects for the development of bio-pharmaceuticals.
  • Understanding and experience in budget establishment, cost control and optimization.
  • Ability to work in a matrix organization.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.