Senior Pharmaceutical Engineer Jobs

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

As a Senior Pharmaceutical Engineer, you will be a member of our Drug Product team and support the development and manufacturing of oral solid dosage forms for late phase clinical studies through post-commercial marketing approval. You will have the opportunity to scale-up and optimize drug product processes for development programs, manage ongoing GMP manufacturing operations, and strategize and execute process validations.

Responsibilities

• Lead troubleshooting and root cause analysis of manufacturing challenges and deviations
• Manage ongoing manufacturing activities for clinical drug products
• Lead the technical review of development and manufacturing documentation, including protocols, reports, and batch records
• Manage process development activities at CMOs for drug products in late-phase development, ensuring a robust process suitable for commercial manufacturing
• Lead the preparation for and execution of process validation activities
• Contribute to drug product sections of regulatory filings such as INDs, IMPDs, and NDAs
• Act as Person-in-Plant during critical activities at CMOs
• Analyze in-process and analytical data, draw scientific conclusions, and provide recommendations as they pertain to process development activities

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Experience designing and executing experiments, as well as drawing conclusions and providing recommendations based on experimental data, and communicating results to senior leadership
• Experience applying Design of Experiment statistical approach during process optimization and scale-up; experience using statistical programs to perform statistical analysis on the data
• Experience troubleshooting during tech transfer and manufacturing activities at CMO
• Deep expertise in manufacturing unit operations for oral solid dosage forms, including granulation, compression, and film-coating
• Ability to travel up to 20%
• BS with 8+ years of extensive industry experience; ideal candidate will have degree in chemical engineering, pharmaceutical sciences, or related fields

Salary pay range: $144,000 - $176,000. Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer