Associate Director Packaging and Serialization

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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 Description:

Cytokinetics is a latestage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing firstinclass muscle activators and nextinclass 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.

We are looking for an experienced Associate Director of Packaging and Serialization to manage and lead related packaging and serialization activities including relevant processes and procedures. This individual will report to the Director of Packaging and Serialization.

Responsibilities:

• Provide technical expertise (i.e. Packaging Technology Package Design Serialization Product Security Packaging Process Development & Optimization etc.

• Process Owner and /or the Lead for one or more processes in packaging and serialization including but not limited to:

  • New Technology Acquisition

  • New Package Introduction

  • Packaging Serialization and Artwork

  • Packaging Process Development and Optimization

  • Identification and qualification of alternate sources for packaging components

• Will develop and maintain the technology capability for packaging and serialization to deliver our services and continuously improve that capability

• Lead manage and execute all aspects of a project. Accountable for delivery including but not limited to:

  • Documentation (Packaging Component Specifications Bill of Materials Validation/Technical Protocols and Reports Validation Master Plan Regulatory Filing Support Documentations etc.

  • Right first time documents

  • Cost of goods productivity improvement for commercial products

  • 100 filing submissions on time and correct

  • 100 Regulatory responses on time and correct etc.

• Will work with external contract packaging network to create or enhance packaging capabilities to deliver the needed capacity quality and quantity of packaged goods required by our patients. Will partner with contractors to ensure quality in product packaging and drive elimination of customer complaints relating to packaging

• Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers Contract packagers Product Strategy Leads Quality Assurance Procurement Business Alliance Research and the Commercial Teams

• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous riskmanagement based solutions to complex technical challenges

• Promote continuous improvement in efficiency quality and safety through technical development education and training

• Lead and conduct complex technical investigations

• Authors reviews approves regulatory and technical documentation including but not limited to CMC SOPs Validation Master Plans Validation Protocols and Technical Reports

• Provide technical perspective during internal and external audits regulatory inspections and due diligence

• Recruit and manage external resources such as Consultants and Contractors as needed to deliver projects

• Interface directly with all Customers and ensure highest level of Customer satisfaction

• To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations
  

Qualifications:

• Bachelor degree in Packaging Science Technology or Engineering with 10 or more years relevant experience in managing technical programs such as:

  • Technology acquisition

  • Equipment qualification

  • Process development scaleup and optimization

  • Package design development

  • Technology transfer

  • Qualification of packaging components from alternate sources

• Ten or more years experience leading highly effective technical teams developing people and in particular technical capabilities

• Experience in global product launches and the associated CMC regulatory requirements

• Advanced knowledge of cGMP/GLP regulations ICH and FDA CMC Guidance Documents is preferred

• Solid organization problem solving projectmanagement decisionmaking judgment and teamoriented skills are essential

• Demonstrated ability to simultaneously manage multiple projects of variable complexity

• Strong technical interpersonal communication and leadership skills
  

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve we believe Cytokinetics will continue to be a pioneering valuesdriven sustainable fully integrated biopharmaceutical company.

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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 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 nonstandard 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

Please visit our website at:

Cytokinetics is an Equal Opportunity Employer

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 ourGeneral Data Protection Regulation (GDPR) policyPRIOR 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 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 nonstandard 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

Please visit our website at:

Cytokinetics is an Equal Opportunity Employer