Associate Director/Director, CMC - Formulations
aurinia pharmaceuticalsSpokane, WA
$190,000 - $260,000
APPLY (opens in a new tab)Associate Director/Director, CMC - Formulations
aurinia pharmaceuticalsSpokane, WAManager L7
$190,000 - $260,000
Pharmaceutical Preparation ManufacturingResearch and Development in BiotechnologyMedicinal and Botanical Manufacturing
About Aurinia Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health. In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease. Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
Position Summary:
The Associate Director/Director, CMC - Formulations will contribute to the oversight, planning and execution of Chemistry, Manufacturing and Controls (CMC) strategy, including drug product formulations, in support of Aurinia’s development programs. In collaboration with internal departments, such as nonclinical, clinical pharmacology and regulatory teams, the Associate Director/Director, CMC - Formulations will contribute to all aspects of chemistry, manufacturing and controls, including design of drug product formulations, oversight of vendors and production of regulatory documents.
Essential Duties and Responsibilities:
- Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals Contribute to CMC and development strategy
- Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs)
- Assist with the clinical supply logistics
- Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents
- Draft, edit and review sections of regulatory and IP documents
- Provide scientific input for analytical protocols and study reports
- Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence
- Participate in business development activities, as requested
Qualifications:
- Bachelor’s degree or higher in life sciences or related discipline required
- Master’s degree preferred
- Minimum of 5 years in relevant pharmaceutical industry work experience requiredExperience with small molecule formulations requiredExperience with biologics formulations preferred
- Experience working with CDMOs and analytical labs
- Experience with one or more of the following drug product formulation strategies: modified/delayed release, fixed-dose combinations, spray-dried dispersions
- Experience with a wide range of excipients and formulation technologies
- Experience with formulations for oral, subcutaneous and/or inhaled delivery Ability to research, synthesize and summarize complex CMC topics
- Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND)/New Drug Application (NDA) sections
- Ability to effectively organize and manage multiple assignments with challenging timelines from project start-up through submission
- Excellent knowledge of Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) regulations and Good Manufacturing Practices (GMP)
- Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
Ability to establish and maintain collaborative working relationships with internal and external stakeholders Desired Competencies Ensures Accountability - Holds self and others accountable to meet commitments. For example, accepts responsibility for own work, both successes and failures. Handles fair share and does not make excuses for problems. Meets commitments to others.
Manages Complexity - Makes sense of complex, high quantity, and sometimes contradictory information to effectively solve problems. For example, looks at complex issues from multiple angles; explores issues to uncover underlying issues and root causes; sees the main consequences and implications of different options.
Plans and Aligns - Plans and prioritizes work to meet commitments aligned with organizational goals. For example, outlines clear plans that put actions in a logical sequence; conveys some time frames. Aligns own work with relevant work groups. Takes steps to reduce bottlenecks and speed up the work.
Instills Trust - Gains the confidence and trust of others through honesty, integrity, and authenticity. For example, acts consistently with the organization's policies and practices. Shows honesty and candor when working with others. Honors agreements and meets commitments.
Collaborates - Builds partnerships and works collaboratively with others to meet shared objectives. For example, readily involves others to accomplish goals; stays in touch and shares information; discourages "us versus them" thinking; shows appreciation for others' ideas and input.
Communicates Effectively - Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences. For example, listens attentively and takes an interest. Keeps others well informed; conveys information clearly, concisely, and professionally when speaking or writing.
Tech Savvy - Anticipates and adopts innovations in business-building digital and technology applications. For example, investigates technologies to learn some cutting-edge best practices.
Business Insight - Applies knowledge of business and the marketplace to advance the organization's goals. For example, clearly understands how own activities relate to critical business drivers. Monitors business news and market changes for impact on the business or on own expertise area; uses this to shape decisions.
Optimizes Work Processes - Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. For example, uses metrics and benchmarks to monitor accuracy and quality. Takes steps to make methods productive and efficient. Promptly and effectively addresses process breakdowns.
Action Oriented - Takes on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm. For example, takes immediate, decisive, independent action to resolve issues or problems. Persists as needed. Quickly and consistently identifies and pursues beneficial new opportunities.
The job description documents the general nature and level of work but is not intended to be a comprehensive list of activities, duties and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow. Aurinia Pharmaceuticals Inc. reserves the right to make modifications to this job description as deemed necessary by changing position and business requirements.
The estimated annual base salary for this position is $190,000 - $260,000, commensurate with experience and skills. This role may be eligible for discretionary bonuses and other incentive programs.
Aurnia provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.
Aurinia provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Aurinia participates in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.
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Level
Manager L7
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Location
Spokane, WA
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Industry
Pharmaceutical Preparation Manufacturing
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