AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Key Responsibilities

• Drive formulation & process development activities for late-stage clinical & commercial programs.
• Lead scale-up, tech transfer, & validation to commercial manufacturing sites (internal & external).
• Manage manufacturing activities including monitoring production campaigns, reviewing of batch records, & process batch data.
• Support resolution of quality investigations or events.
• Author & review CMC sections for regulatory submissions.
• Present technical data & strategic decisions to cross functional teams & senior management.

Education & Experience

Must have a BS in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering, biotechnology or related discipline, & 5 years’ experience as a functional area lead managing small molecule oral solid drug product development.

Of experience required, must have 5 years:

1. leading late-stage oral tablet formulation development, scale-up, formulation characterization, &  optimization, and process validation;
2. operating under cGMPs &  associated regulatory &  quality compliance in the pharmaceutical development & manufacturing environment;
3. overseeing clinical supply manufacturing;
4. preparing, written & oral reports, for peers, management &  business stakeholders within a matrixed organization.

Alternatively, would accept MS in pharmacy, pharmaceutics, chemistry, chemical engineering, pharmaceutical engineering,  biotechnology or related discipline & 2 years’ experience as a functional area lead managing small molecule oral solid drug product development.   Of experience required, must have 2 years of (i), (ii), (iii), & (iv).

With either combination of education & experience required, must have experience writing CMC sections in at least 3 regulatory submissions for late stage clinical or commercial applications.

Experience may be gained concurrently. Would accept any suitable combination of training, education & work experience.

100% Telecommuting permitted.

Salary Range: $164,800.00 - $230,000.00 per year.

Apply online at https://careers.abbvie.com/en or send resume to [email protected]. Refer to Req ID: REF45973K

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We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.  This job is eligible to participate in our short-term and long-term incentive programs.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html