Job Description

Associate Principle Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) (m/f/d)

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world

We are currently looking for an experienced Associate Principle Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) (m/f/d) to be based in our new office in Zürich. (full-time, indefinite).

Under direction from Director/Executive Director, the Assoc Principle Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Assoc Principle Scientist (m/f/d) is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principle Scientist (m/f/d) will assist in or be part of team that is responsible for development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects.

THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:

• Participation in the authorization process to prioritize submissions
  
• In depth knowledge of global CMC guidelines including but not limited to clinical submissions (IND/IMPD), marketing application (original and supplemental), and/or post approval changes / variations
  
• Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines
  
• Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs or post approval change documentation according to defined timelines
  
• Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply
  
• Lead authoring of clear, concise and effective submissions according to defined timelines
  
• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions
  
• Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate
  
• Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed
  

QUALIFICATIONS:

• Bachelor in a science, engineering, or a related field such as Pharmacy, Chemical or Biological Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry
  
• Advanced degree would be strongly preferred
  
• A minimum five years of Industrial/regulatory experience in biologics research, development and/or manufacturing
  
• Prior Biologics clinical submissions, marketing applications or post approval changes / variations filing experience
  
• Fluency in English (oral and written), German nice to have
  
• Willingness to travel up to 10%
  
• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
  
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data
  
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner
  
• Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills
  
• Experience in Device Development or Vaccines is a plus
  

THE COMPANY
Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

The recently opened new location in Zurich focuses on accelerating research, data and commercialization of our medicines and vaccines. The new office will be staffed by teams working in strategic and operational roles in medical affairs, clinical development, access and marketing operations functions.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply 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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/22/2024

• 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.
  

Job Posting End Date:09/22/2024

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.


Requisition ID:R308112