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Job Title: Senior Scientist III, Technical Lead (Analytical Development)

Department: Analytical Development

Reporting To: Director, QC/AD

Classification: Exempt

Salary Range: 115k-140k

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 10 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 Senior Scientist III, Technical Lead, Pharmaceutics performs and leads analytical development activities and tasks to support formulation development and drug product manufacturing and manages work schedule. The Senior Scientist facilitates, plans, and manages the execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC. Responsible for performing advanced experiments and general laboratory duties.

The Senior Scientist III, Technical Lead, continues their duties as individual contributor and works with the Director, Pharmaceutics to provide technical support expertise to the team, ensuring proposals are prepared and projects are completed to standard. They will be determining project requirements and timelines, communicate with Senior Scientist, Logistics Manager and Director of Pharmaceutics to enhance milestone and task achievements. The Senior Scientist, Technical Lead, will be keeping up to date with industry trends and set up training sessions for all team members to develop analytical team individual skills.

Essential Functions and Responsibilities

• Subject matter expert for analytical activities
• Train and provide technical support to internal team and customers
• Review existing technologies and propose improvement to equipment train and technology offerings
• Mentor junior scientists and develop team with skill matrix
• Independently conducts complex analyses with a thorough understanding of laboratory procedures.
• Leads in drug product program as analytical development chemist to collaborate with other departments and support formulation development and manufacturing activities with pre-set timelines.
• Develops and validates complex methods including stability indicating methods independently for early phase drug product development.
• Evaluated and optimizes existing analytical methods to suit its purpose.
• Investigates aberrant results, determination of root causes and recommends action plan.
• Interacts with clients by providing updates and participating technical discussions through regular phone calls and emails.
• Responds quickly to client requests and adjusts to priorities changes accordingly.
• Works with advanced methods and designs and performs advanced experiments accurately, consistently, and in a timely manner.
• Performs data analysis using Empower, Excel spreadsheets and other necessary tools.
• Writes/revises Standard Operating Procedures (SOPs), analytical methods, protocols and technical reports.
• Assist and mentor junior level Scientists on analytical techniques training and troubleshooting issues.
• Complies with all laboratory safety guidelines including Personal Protective Equipment (PPE).
• Maintains general cleanliness of the lab, including personal bench space and common use areas.
• All other tasks and duties assigned as perceived and agreed upon by management.
• This job description is subject to change at any time.

Requirements

• BS degree in Chemistry or related scientific discipline with 10+ years of relevant experience
• MS in Chemistry or related scientific discipline with 7+ years of relevant experience
• PhD in Chemistry or related scientific discipline with 5+ years of relevant experience
• Track record of analytical method development and validation
• Knowledge of cGMP, USP and ICH guidelines related to method development and validations
• Solid understanding of analytical chemistry and theory of analytical instrumentation.
• Demonstrated practical and theoretical knowledge of multiple applicable analytical techniques for pharmaceutical testing.
• Proven problem solving and troubleshooting abilities on method or instrument issues.
• Experience in independently optimizing and developing analytical methods.
• Ability to train junior staff.
• Hands-on experience utilizing analytical equipment such as HPLC/UV, UPLC, Dissolution, GC/FID, Karl Fisher Titration, UV/Vis, FTIR, etc.
• Proficient in Empower Software.
• Good written and oral communication skills.
• Ability to work in a team and collaborative work environment
• Strong organizational skills and attention to detail.
• 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

• Experienced in technical leadership within analytical development for operating under cGMP standards.
• CMO or CRO experience
• Improvement of any aspect of laboratory processes
• Detailed attention to data trending
• Exceptional information technology skills
• Good technical writing skills
• Strong method development skills
• Good attitude, work ethic, and natural leadership
• Achievement of an advanced degree

Benefits

Position 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.