Associate Director, CMC Analytical

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.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

This position will coordinate and oversee analytical development and commercial testing at contract testing laboratories for drug substance, drug product and Stability Programs for development and/or commercial product portfolio. This individual will have strong experience and quality mindset in managing quality records. This individual will support regulatory filings and provide technical leadership role in improving operational procedures and best practices.

Responsibilities

Work closely with cross functional team members, Pharmaceutical Development, Manufacturing, Global Supply Chain, Quality Assurance and CMC Regulatory Affairs to manage analytical methods transfers, methods validation, data oversight and ensure timelines coincide with process development and production schedules. This includes, but is not limited to:

• Oversee analytical activities at CMO and CTL laboratories, including method development, validation, release and stability activities. Perform data review, external auditing, exceptions management (Deviations, CAPAs, OOS/OOT), and change control as it relates to GMP quality testing for small molecule pharmaceutical products. Ensure contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet the desired quality standards of the Company.

• Provide analytical development support to drug substance development and formulation development activities. Support commercial manufacturing activities.

• Lead analytical method development, validation, and transfer activities, support development, manufacturing site change, scale up and post approval changes.

• Lead the development and management of stage appropriate stability programs

• Lead the establishment and justification of all specifications for drug substances and drug products. Author justification of specification reports.

• Author relevant technical sections in IND/IMPD/CTD supporting global CMC regulatory submissions. Author/review responses to regulatory questions.

• Contribute to appropriate sections of Annual Product Reviews for applicable products.

• Support operational budgets, cost controls and resource planning to meet corporate strategic objectives.

• Serve as an SME for analytical methodologies, specifications, stability, reference standard, etc. during regulatory inspections, internal and external audits. Support corporate and third-party inspection readiness activities and health authority inspections.

• Keep abreast of industry developments – new technology, forthcoming regulations, competitor activity, etc.

• Additional duties and responsibilities as assigned

Qualifications

• Advanced degree in Analytical Chemistry or related discipline with 10 + years of pharmaceutical industry experience in Analytical Development (AD), as well as Quality Control (QC)

• Demonstrated record of excellence in leadership and management of AD/QC activities in a small molecule drug development and commercial production industry environment

• Experienced in leading AD/QC teams in support of commercial and development stages projects

• Experience in analytical activities supporting drug substance and pharmaceutical oral solids is a must.

• Expert knowledge and hands-on experience with chromatographic methods and modern analytical instrumentation

• Highly organized and self-motivated, with strong leadership, team building, organizational, and interpersonal skills

• Excellent written and oral communication, presentation, and organizations skills are essential.

• Demonstrated ability to work in multi-disciplinary settings acting as facilitator and coach.

• Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations pertaining to pharmaceutical manufacturing, method validations, product specifications, stability programs and other QC/AD activities

• Demonstrated ability to manage external contractors to meet or exceed Company goals

• Proficient with MS Office and laboratory systems. Proficient in writing technical reports and AD/QC sections of CMC regulatory documents. Working knowledge of applicable business systems including: Veeva, LIMS, etc.

• Demonstrated ability to effectively manage multiple products and projects

• Experience in creating, searching, and retrieving records in an Electronic Notebook system

#LI-HYBRID

Pay Range:

In the U.S., the hiring pay range for fully qualified candidates is $171,000-$199,500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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