Principal Scientist, Formulation Development

Job Title: Principal Scientist, Formulation Development

Department: Formulation Development

Reporting To: Director, Pharmaceutics

Classification: Exempt

Salary Range: $141,000-$155,000/yr

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees.  Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Principal Scientist, Formulation Development will be responsible for leading projects focused on the formulation development of solid oral drug candidates for preclinical and human clinical studies. This role will have a major focus on the design and development of drug delivery systems and dosage forms, including use of technologies such as spray drying and Hot Melt Extrusion. This role will involve hands-on laboratory work and mentoring and training of scientists. All duties will be performed in compliance with BioDuro’s standard operating procedures (SOPs) and GMP regulations.

Essential Functions and Responsibilities

• Independently performs and implements formulation strategies.
• Leads investigations of aberrant results, determines root causes, and recommends action plans.
• Prepares scientific reports and experimental protocols.
• Provides internal technical guidance to the formulation, analytical, and manufacturing teams on formulation methodologies and issues.
• Routinely acts as a group leader on formulation projects.
• Represents the formulation team as a subject matter expert.
• Complies with BioDuro SOP and cGMP practices in documentation and equipment operation.
• Responsible for enhancing the scientific and technical expertise of the formulation operations.
• Provides internal technical guidance to the formulation, analytical, and manufacturing teams on formulation methodologies and issues.
• All other tasks and duties assigned as perceived and agreed upon by management.
• This job description is subject to change at any time.

Requirements

• Ph.D. in chemistry or related scientific discipline with 6+ years (PhD), 10+ years (MS), or 15+ years (BS) of relevant industry experience
• Hands-on experience working on tablets, capsules, etc., using dilution blend, dry granulation, wet granulation, and other commonly used process approaches (experience in hot-melt extrusion and spray drying is must), functional coating (Delayed and Sustained Release).
• Proven scientific leadership in multiple areas of formulation chemistry in CMC drug development
• Successfully lead technical teams in developing and commercializing pharmaceutical drugs in one or more industry organizations.
• Demonstrated ability to establish new capabilities and innovate strategies in pursuit of scientific excellence.
• Experience with supervision, mentorship, or management of other team members.
• Ability to work in a well-lit heated and/or air-conditioned indoor office and occasional laboratory setting with adequate ventilation. Light physical activity performing non-strenuous daily activities of a productive/technical nature. May require long periods of standing/sitting.

Preferred Qualifications 

• Understand the functionality and chemistry of excipients and drug substances
• Able to react to change productively and handle other essential tasks as assigned
• Manages personal and interpersonal stress, if required
• Strong mathematic and chemistry skills
• Has the discipline to stay focused and complete specific tasks
• Has excellent verbal and written communication skills
• Excellent organizational skills
• Good troubleshooting and interpretation skills
• Strictly follows the company policy on client confidentiality

Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@BioDuro-Sundia.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.