Cytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
As a Pharmaceutical Engineer II/III, 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 support the scale-up and optimize drug product processes for development programs, support ongoing GMP manufacturing operations and process validations.
Responsibilities
- Support process development activities at CMOs for drug products in late-phase development, ensuring a robust process suitable for commercial manufacturing
- Support ongoing manufacturing activities for clinical drug products
- Support technical review of development and manufacturing documentation, including protocols, reports, and batch records
- Analyze in-process and analytical data, draw scientific conclusions, and provide recommendations as they pertain to process development activities
- Support troubleshooting and root cause analysis of manufacturing challenges and deviations
- Support the preparation for and execution of process validation activities
- Support or create manufacturing documentation including change controls, action items, and deviations.
- Support in house drug product development batch manufacturing if necessary
- Act as Person-in-Plant during critical activities at CMOs
- Contribute to drug product sections of regulatory filings such as INDs, IMPDs, and NDAs
- Support post approval manufacturing activities including tech transfers and cleaning validation
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
- BS with 2+ years of extensive industry experience; ideal candidate will have degree in chemical engineering, pharmaceutical sciences, or related fields
- Experience in manufacturing unit operations for oral solid dosage forms, including granulation, compression, and film-coating
- 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 with working with drug product CMO
- Experience troubleshooting during tech transfer and manufacturing activities at CMO
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 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.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
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
