Nature and Scope

The R&D Formulation Manager will be responsible for the operation and management of Formulation R&D. The individual will lead formulation and process development for discovery and development of drug product and provide the guidance to the scientists. The individual will work closely with the R&D analytical to ensure that project timelines are met.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Manage Formulation Development for New Products.
• Provide technical leadership for the design and execution of Quality-by-Design (QbD) product development studies and development of scalable manufacturing process for parenteral drugs.
• Manage and communicate daily activities of formulation laboratory to ensure that all the assigned projects are completed on time. Ensure that accurate and complete laboratory records are maintained in the group in compliance with company policy and Good Manufacturing Practices (cGMP) requirements.
• Manage formulation team in design and execution of laboratory experiments to optimize formulation for performance and stability, study material compatibility and evaluate sterilization options.
• Review and approve R&D study protocols and reports, Tech Transfer reports, Pharmaceutical Development reports, etc.
• Manage FDA deficiency and audit activities and work with RA for new and existing submissions.
• Manage formulation activities to support product or process/technical troubleshooting, special investigations and product complaints.
• Support Tech Transfer activities and support trouble shooting of manufacturing issues.
• Attend department management meetings and schedule work to align with department objectives.
• Mentor Scientists/Chemists in key formulation techniques and essential formulation equipment.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, Good Documentation Practices, and health and safety requirements.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Masters or Ph.D. degree in Pharmaceutical Sciences, Chemistry, or equivalent required.

• Minimum of 7-10 years pharmaceutical industry experience, of which at least 1-2 years are in a supervisory/management position.

• Broad knowledge of formulation development following the QbD principles, formulation characterization, process development, and scale-up of sterile injectable products is essential.

• Strong scientific background and solid understanding of parenteral drug product manufacturing is essential.
• Experience in development of long-acting, suspension, and freeze dried parenteral products is a plus.
• Knowledge and/or experience in pharmaceutical product lifecycle management is a plus.
• Knowledge on nanoparticle technology, suspension and aseptic process is a plus.
• Ability to deep dive into the literature and extract the information and test the hypotheses.
• Must be self-motivated and passionate about performing research that may lead to the treatment of human disease.
• Ability to make decisions independently and with appropriate input.
• Ability to work well in a matrix environment, particularly with QA/QC, Manufacturing Operations, Project Management and Regulatory Affairs.
• Flexibility in adapting to multiple therapeutic areas interchangeably, and ability to prioritize/manage multiple, parallel projects/tasks.
• Strong computer skills (Word, Excel, PowerPoint, and Outlook) and presentation skills.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.

Expected Salary Range:

$132,800- $145,000

The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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