Director, CMC Compliance

A brief overview

The Director, CMC Compliance (QA) fulfills a critical role by leading a team of skilled QA professionals who support the development of new NCEs and Generics as well as the life cycle management of Bachem's product portfolio. This individual provides guidance to internal and external stakeholders applicable to pharmaceutical drug development and manufacturing and ensures compliance of NCEs and Generics with all applicable regulations. This individual also directs project teams in support of clients to bring new medications through the drug development process. Directly, and through staff, this individual performs the essential functions described below.

What you will do

• Provides guidance to internal and external stakeholders (e.g. Manufacturing, QC, RA, customers) to ensure compliance of NCEs and Generics with all the laws, regulations, and guidance applicable to pharmaceutical drug development and manufacturing.
• Ensures compliance and continuous improvement of Bachem America’s CMC development concept. Supports alignment of CMC development concepts across Bachem sites.
• Represents Quality Assurance in NCE, Generics and commercial project teams.
• Represents Quality Assurance during customer visits and regulatory audits.
• Supports responses to customers RFP’s and contributes to the preparation of quotations for projects and services.
• Negotiates and approves quality agreements with customers
• Supports the annual product portfolio review
• Stays abreast of CMC development requirements and pursue continuous improvement throughout the organization

Qualifications

• Bachelor's degree in organic chemistry or related field
• Master's Degree in Organic chemistry or related field (preferred)
• 10+ years’ experience in pharmaceutical or device industry
• 4-6 years’ managerial experience in cGMP manufacturing
• 7-9 years’ experience in Peptide and/or Oligonucleotide and/or equivalent API development & manufacturing (preferred)
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment

Base salary range: $167,354 - $208,645

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

 Corporate Social Responsibility

 Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness.  EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.