• Senior R&D Director (oral solid dosage)

    ManpowerGroup (Crystal, MN)


    We are seeking a highly experienced **Senior Pharmaceutical R&D Director** to lead scientists and complex development programs in **oral solid dosage forms** within the generics space. This individual will oversee strategy, development, and execution of **multi-particulate and modified-release (MR) dosage formulations** , ensuring regulatory compliance and successful market launches.

     

    The ideal candidate brings a proven track record of **developing complex generic oral solid products** , including those requiring **bioequivalence to reference products with defined pharmacokinetic profiles (AUC, Cmax, Tmax requirements)** .

     

    **Job Title:** Senior Director of R&D (oral solid dosage)

    **Location:** Minneapolis, MN

    **Salary:** 180-240k + short and long term bonuses

    Key Responsibilities

    + Provide strategic leadership and technical oversight for the development of **complex oral solid dosage forms** , including **multi-particulate systems** and **modified-release formulations** .

    + Direct and mentor cross-functional teams (formulation, process development, analytical, regulatory, manufacturing) to advance projects from concept to commercialization.

    + Oversee **ANDA submissions** for generic products, ensuring alignment with regulatory expectations for **bioequivalence studies and AUC-based requirements** .

    + Guide formulation development strategies for complex generics, balancing scientific innovation with regulatory and commercial considerations.

    + Evaluate and implement new technologies for controlled-release, multiparticulate systems, and advanced polymer/drug layering methods.

    + Collaborate with clinical and regulatory affairs to design development programs that meet **FDA and global regulatory bioequivalence standards** .

    + Serve as a subject matter expert (SME) for oral solid dosage development, providing leadership in technical due diligence for business development opportunities.

    Qualifications

    + Advanced degree in **Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline** (PhD preferred, Master’s with extensive experience considered).

    + **15+ years of pharmaceutical R&D experience** , with a strong focus on **oral solid dosage forms in generics** .

    + Demonstrated expertise in **multi-particulate and complex MR dosage forms** (pellets, beads, mini-tablets, layered systems).

    + Proven success in developing products with **AUC/bioequivalence requirements** , including regulatory submission and approval.

    + Deep knowledge of **ANDA regulatory pathways** and requirements for complex generics.

    + Strong leadership background with experience managing and developing technical teams.

    + Excellent communication skills and ability to influence at senior leadership and regulatory levels.

    Benefits

    + Medical, Dental, & Vision with HSA and FSA plans

    + PTO Plan

    + Short and long term bonuses

    + Retirement plans including a 401K match

    + Supplemental Life Insurance & Disability Plans

    + ESOP

     

    If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

    About ManpowerGroup, Parent Company of Experis

    _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

     

    ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.