Report this Job
Job Title: Scientist, Analytical Development
Department: Analytical Development
Reporting To: Director of Analytical Development
Classification: Exempt, Full-Time
Salary Range: 80k-95k
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 Scientist, Analytical Development independently performs analytical development activities and tasks to support formulation development and drug product manufacturing. The Scientist facilitates and assists in 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.
Essential Functions and Responsibilities
- Understands and independently conducts complex analyses of formulation samples and finished pharmaceutical product with a thorough understanding of laboratory procedures.
- Acts as analytical lead with some technical guidance and direction from management or senior scientists 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 analytical methods with some technical direction and guidance
- Optimizes existing analytical methods to suit their intended purpose with some technical direction and guidance.
- Works with advanced methods and performs advanced experiments accurately with minimal technical guidance, consistently, and in a timely manner.
- Performs documentation and data analysis using Empower, Excel spreadsheets, and other necessary tools.
- Writes/revises Standard Operating Procedures (SOPs) and methods when necessary.
- Assists other Scientists with assigned projects.
- 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 senior management.
- This job description is subject to change at any time.
Requirements
- BS degree in Chemistry or related scientific discipline with 3-5 years experience
- MS in Chemistry or related scientific discipline, with 2+ years experience
- PhD in Chemistry or related scientific discipline
- 2-4 years of experience in analytical laboratory positions in pharmaceutical industry.
- Experience utilizing analytical instruments such as HPLC, KF, Dissolution Apparatus, UV/Vis, etc.
- Full computer literacy and knowledge of basic scientific principles and practices.
- cGMP and regulatory knowledge on method validations
- Able 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
- Improvement of any aspect of laboratory processes
- Detailed attention to data trending
- Exceptional information technology skills
- Good data interpretation skills
- Good technical writing skills
- Good problem-solving development skills
- Good attitude, work ethic, and natural leadership
- Achievement of an advanced degree
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.
BioDuro-Sundia
