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.

Job purpose

As the Associate Director, External Manufacturing and Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within Manufacturing and External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Director, External Supply Operations.

Responsibilities

Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues
Ensure timely and effective execution of all manufacturing and supply plans at assigned CMO’s
Develop and manage production processes to support operational execution, including BOM’s, specifications, CAPA’s, change controls, master data, and artwork. Familiarity with ERP/MRP systems
Support logistics, transportation and import/export activities
Act as the manufacturing and supply chain representative for review and approval of documentation including but not limited to batch records, BOM’s, specifications, artwork, and change control
Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls
Play a key role in supporting selection and onboarding of new CMOs, technical transfers, operationalizing product supply and site establishment
Manage and track inventory, perform inventory reconciliations, and support month end close process.
Issue purchase orders, and track invoices and budgets
Maintain production schedules and track batch record execution in coordination with Quality
Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation
Proven risk management acumen with a continuous improvement mindset
Where necessary, provide input to the manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
Build and maintain strong partnerships and provide effective communication with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded
Responsible for scheduling and maintaining routine business operations meetings with CMO’s
Support Regulatory submissions and CMC as required

Qualifications

Education & Core Experience

BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired
10+ years’ combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry
cGMP career experience embedded in a pharmaceutical manufacturing plant is essential – with first-hand knowledge of plant operations, with the insight to assess performance, and diagnose issues directly at the source
Technical background with knowledge of engineering and pharmaceutical manufacturing processes in small molecules is required, and experience in DS/API production is desirable
Excellent problem-solving skills, with the ability to address complex challenges under time pressure
Demonstrated expertise in risk management, with a history of successfully implementing risk mitigation strategies
Hands-on investigations/RCA (OOS/OOT/deviations) and continuous improvement at external sites
The ability to function in a fast-paced, high-growth, entrepreneurial environment
Ability to travel domestically and internationally ~25%
Position requires a strong working knowledge and understanding of both regional and international regulations by government agencies affecting the pharmaceutical industry (CFR's, EU GMP, ICH)
Timely and effective communication across multiple audiences, both verbally and in writing

#LI-HYBRID

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

Associate Director, External Manufacturing and Supply

Job Description