Manager Analytical Development

The Manager Analytical Development (on-site) manages the analytical development group within the PDS department for CDMO new product development,

technical transfer, and or any additional method development work per client

request or change order. This important role is accountable for the overall

success of the group for meeting project timelines and within quotation

budgets. This position client facing, and responsible for participating in client meetings, on-site technical visits, and laboratory tours. This leadership role will also participate in the quotation process when proposal requests arrive from clients.

Other responsibilities include hands on bench work when needed, performance reviews, coaching, mentoring, resource allocation and budget planning,

execution and financial reporting. Fosters innovation and drives new technology evaluation and application. Provides broad analytical and technical leadership within PDS. This position may also lead or serve as a resource for

multidisciplinary teams to resolve critical and complex technical or process issues.

Essential Duties:

• Manage Analytical Development Group and hands on work when necessary.
• Interact with potential clients through technical calls, on-site visits, tours, and serves as the SME in all AD work.
• Execute client RFP quotes for the analytical activities in a very timely manner.
• Collaborate with QC during projects work and method transfer activities.
• Serve on project teams and presents technical data related to analytical work.
• Generate change controls, specifications, protocols or other administration work as needed to move projects along.

Requirements:
PhD in Analytical Chemistry, Pharmaceutical Science, Chemistry or other related disciplines with minimum of 10 years of relevant pharmaceutical analytical

development experience in a GMP environment. Alternatively, a MS/MBA with minimum of 13 years of relevant pharmaceutical analytical development

experience in a GMP environment, or BS with minimum of 15 years of
relevant pharmaceutical analytical development experience in a pharmaceutical GMP environment.

Solid oral dose analytical drug development on complex programs is a must.
Prior CDMO experience is a bonus. Must have at least 4 years of previous

experience in managing a group of at least 3 individuals. Alternatively, must have at least 4 years of influence leadership experience leading cross-

functional teams and a demonstrated track record of success mentoring junior scientists. Demonstrated ability to work on or oversee multiple projects and
meet timelines. Knowledgeable in HPLC and GC method development for stage appropriate drug development. Knowledgeable in current analytical

methodologies for trace level impurity identification and quantitative analysis. Thorough knowledge of FDA guidance for the industry, and ICH guidelines as they related to DS and DP characterization, control, and stability.
Thorough knowledge in GMPs as they relate to analytical support, drug

substance manufacture process, and other relevant focus areas. A successful track record in providing regulatory submission documents for IND, NDA, and ANDA.

Other Knowledge, Skills and Abilities:
* Ability to multitask, prioritize, and work under pressure with competing tasks
* Initiative and drive to learn and master complex new field and tasks
* Good Microsoft Office software skills and experience with related software
* Ability to maintain personal and shared workspace in an organized manner

Certifications / Licenses
Auditing Certification

Compensation Range:

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rightscommission activity, status as a protectedveteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.