Regulatory Affairs Intern

Location: Germantown, Wisconsin, US
Department: Quality
Reference: VN858
About Sterling’s Summer Internship Program
The Sterling Summer Intern Program is a paid 13-week program from May 20 – August 16, 2024. Sterling interns are provided hands-on work experience building upon knowledge and skills learned in the classroom. Interns work side-by-side industry leaders in a dynamic, fast-paced environment who are passionate about being part of a team developing life-saving drugs around the world. Throughout the 13-week program, interns will work on defined individual projects to learn about GMP fundamentals and techniques from Sterling professionals. The program concludes with individual presentations to Sterling leaders.

Your Responsibilities
As the Regulatory Affairs summer intern, you will report directly to the Regulatory Affairs Specialist and you will gather, trend, and assess GMP data to support the generation of Annual Product Reviews, a critical component to maintaining compliance to the Federal Code of Regulations for active pharmaceutical ingredients. This role will also help collect document change control information to further support Annual Product Reviews, as well as Drug Master File amendments.

The position requires behaviors of the Sterling values and non-negotiables, as well as expertise in functional competencies included in this position summary.

Requirements for the Role
  • Enrolled in a 2 or 4-year college or university pursuing a Bachelor’s degree in Chemistry, Biology with a Chemistry Minor or Pharmaceutical Sciences of at least a Sophomore level.
  • Cumulative GPA of 2.75 or higher.
  • Excellent verbal and written communication and documentation skills required.
  • Excellent detail orientation and organizational skills required.
  • Excellent problem-solving and basic trouble-shooting ability required.
  • Ability to handle multiple tasks.
  • Awareness or prior work experience in a GMP environment preferred.
  • Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
  • Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin.  A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees.  All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why Consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
 
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
 
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 
 

Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent. Be willing. Be reliable.