Associate Director, Formulations
Company: Mallinckrodt Pharmaceuticals
Location: Saint Louis
Posted on: February 25, 2021
Job Title Associate Director, Formulations Requisition
JR000011141 Associate Director, Formulations (Open) Location
Webster Groves (Pharma) - USA038 Additional Locations St. Louis, MO
Job Description SummaryMallinckrodt Pharmaceuticals is seeking a
highly motivated and experienced Associate Director in generic
dosage product development. The successful candidate for the
position will lead and oversee planning and execution of
formulation development and tech transfer for scale up,
registration and validation activities at both internal and
external manufacturing sites. This position will be a technical
mentor for junior formulation scientists to guide the successful
generic dosage products. The candidate will serve as a key driver
to identify, analyze, suggest and own improvement actions to build
a high performance organization. This position may require some
travel to assist in tech transfer and manufacturing-related
activities across the GMP manufacturing sites.--Essential
- Leads and oversees the formulation development and tech
transfer of generic oral dosage products.
- Manages formulation and tech transfer-related activities
including detailed planning of the formulation and process
development, scale-up activities, registration batch manufacturing
and pre- and validation support at a commercial manufacturing
- Responsible for working with lead scientists to establish sound
development strategies and modifying strategies as projects advance
or technical challenges are encountered.
- Works in close collaboration with other functional teams
including Analytical, Project Management, Clinical, Quality,
Regulatory, Legal and Commercials.
- Actively communicates, collaborates with and contributes to
other functional areas to solve problems and achieve goals.
- Authors and reviews formulation related sections for regulatory
filings, development reports and other development related
- Provides troubleshooting at scale-up/commercial level.
- Manages multiple projects; manages project timelines and
- Manages, coaches, mentors, and advises other formulations
scientists in order to meet project goals and timelines.
- Other duties as assigned with or without accommodation.
- Ensures work practices and procedures are safe. In addition,
ensures compliance with corporate and departmental safety
requirements and safety training.Minimum RequirementsEducation /
Experience / Skills:
- PhD in pharmaceutical sciences or related science field with
minimum of 8 years of experience in pharmaceutical formulation
development, working on generic immediate and extended release oral
dosage products, or;
- MS degree with minimum of 10 years of related experience,
- BS with minimum of 14 years of related experience
- Minimum of 3 years of experience in managing a formulations
- Extensive knowledge of manufacturing process-related equipment
for oral dosage products.
- In-depth, hands-on experience in formulation for oral solid and
liquid pharmaceutical dosage forms and various delivery system
- Hands-on experience supervising, leading and training scientist
and other laboratory personnel required.
- Advanced working knowledge of pharmaceutics, pharmaceutical
sciences, and clinical pharmacokinetics required.
- Demonstrated knowledge, experience, and track record in
pharmaceutical manufacturing process in the oral dosage area.
- Working knowledge of evaluating patents and literature prior
- Working knowledge of FDA and ICH guidelines to comfortably lead
multiple projects from concept through validation and launch.
- General knowledge of pharmaceutical analytical techniques.
- Mastery of pharmaceutical concepts, and application of those
concepts and techniques to effectively resolve technical
- Extensive experience in technical writing, including not
limited to protocols, summary reports, product development reports
and CMC-related documents for regulatory filings.
- Excellent verbal and written communication skills.Competencies:
- Excellent communication and interpersonal skills to collaborate
with others including both internal teams and external
- Formulation development team management experience
- This position reports to the Sr. Director Formulations and has
- Partners closely with marketing, clinical, regulatory affairs,
legal, project managers, and manufacturing.Working Conditions:
- Typical laboratory environment.
- Ability to work in the lab.
- Ability to travel 10 - 20%.
- Must pass a security clearance.Disclaimer:The above statements
are intended to describe the general nature and level of work being
performed by employees assigned to this classification.-- They are
not intended to be construed as an exhaustive list of all
responsibilities, duties and skills required of employees assigned
to this position. Posted 13 Days Ago Full time JR000011141 About Us
Mallinckrodt is a global specialty p harmaceutical business that
develops, manufactures, markets and distributes specialty
pharmaceutical products. Areas of focus include therapeutic drugs
for autoimmune and rare disease specialty areas like neurology,
rheumatology, nephrology, ophthalmology and pulmonology;
immunotherapy and neonatal respiratory critical care therapies; and
analgesics and central nervous system drugs. The company's core
strengths include the acquisition and management of highly
regulated raw materials; deep regulatory expertise; and specialized
chemistry, formulation and manufacturing capabilities. The
company's Specialty Brands segment includes branded medicines; its
Specialty Generics segment includes specialty generic drugs, active
pharmaceutical ingredients and external manufacturing. Mallinckrodt
Pharmaceuticals ("the Company") maintains a continuing policy of
non-discrimination in employment. The Company is an equal
opportunity employer and complies with all applicable laws
prohibiting discrimination based upon age, ancestry, color,
religious creed (including religious dress and grooming practices),
disability (mental and physical), marital status, medical
condition, genetic information, military and veteran status,
national origin (including language use restrictions), political
activities or affiliation, race, sex (including pregnancy, child
birth, breastfeeding and medical conditions related to pregnancy,
child birth or breastfeeding), gender, gender identity and gender
expression, sexual orientation, as well as any other category
protected by law. Furthermore, it is our policy to provide equal
opportunity to individuals with disabilities and protected veterans
in all phases of the employment process and in compliance with
applicable federal, state, and local laws and regulations on every
location in which the company has facilities. This policy of
non-discrimination shall include, but not be limited to, the
following employment decisions and practices: recruiting, hiring;
promotions; demotions or transfers; layoffs; recalls; terminations;
rates of pay or other forms of compensation; selection for
training, including apprenticeship; and recruitment or recruitment
advertising. Mallinckrodt Pharmaceuticals is required to report
certain payments or transfers of value (such as expense
reimbursement, meals, transportation) made to U.S.-licensed
healthcare professionals in compliance with the federal Physician
Payment Sunshine Act (i.e. Open Payments) and certain state
Keywords: Mallinckrodt Pharmaceuticals, St. Louis , Associate Director, Formulations, Executive , Saint Louis, Missouri
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