Why Join Bend Bioscience?
Mission and Culture :
At Bend Bioscience, we Advance Health Through Innovation by developing and manufacturing therapies that improve patients' quality of life. We believe every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you're involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.
Do you :
- Love finding new and better ways to do things?
- Want to help develop medicines that improve patients' lives?
- Have a passion for learning and growth?
- Nerd out on science and technology?
- Value collaboration and teamwork?
- Embrace audacity and entrepreneurial thinking?
- Prioritize safety and lead by example?
- Care deeply about doing the right thing?
At Bend Bioscience, we foster a diverse, inclusive, challenging, and supportive culture. We are committed to continuous improvement, both as individuals and as an organization, and we encourage personal and professional development at every level. Join us to make a real difference in patients' lives through your work.
Your New Role At Bend Bioscience :
In this role, you will support product development strategies on client projects and provide strategic input into departmental activities to ensure flexibility and timeliness in achieving client timelines. You will be responsible for the formulation development and process optimization of challenging pharmaceutical products such as controlled-release oral solid dosage forms (tablets, multiarticulate, etc.).
You will also :
Independently leads development activities for client-based projects, ranging from preclinical studies to NDA approval. This will include creating phase appropriate strategies for customer-defined product development projects.Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, troubleshooting product / process issues, and risk assessments.Write, review, and approve cGMP documentation including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.Attend cGMP training sessions and comply with site-wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.Serve as lead for product development activities within pharmaceutical development group and on cross-departmental project teams, working closely with cross-functional groups to achieve project deliverables.Partners with the Department Director and other research experts to develop new concepts. Assists in developing project plans, business analysis, department budget planning and feasibility assessments.Identify and develop specific training content to support ongoing development efforts. Provide leadership and mentorship to junior team members. Support in developing group priorities, goals and objectives and support staff in achieving objectives. Ensure staff is adequately trained to perform jobfunctions.
Education and Experience
Generally, twelve (12) years of experience in formulation and process development of oral solid dosage forms (tablets, capsules, multiparticulates) with a bachelor's degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology Or a master's degree witheight (8) years of relevant experience.
Generally, One (1) year of experience leading and managing teams.Knowledge, Skills, and Abilities
In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.Proven experience with statistical design of experiments.Strong written and oral communication skills.Proficient in MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.Ability to prepare presentations, speeches, and articles for publication that conform to prescribed style and format.Ability to present technical presentations to management, research teams and clients / potential clients to ensure understanding and responding to complex questions.Ability to apply logical or scientific thinking principles to a wide range of intellectual and practical problems.Strong working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations.Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
