Sr. Project Manager

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

Ready to be part of a team with purpose? Look no further, we are hiring for a talented Senior Project Manager, Manufacturing Systems to join our Kindeva team. 

OVERVIEW

Kindeva is a leading contract device and manufacturing organization (CDMO) that provides complex and unique services to pharmaceutical-based customers. The company was recently formed from a merger of Kindeva Drug Delivery and Meridian Medical Technologies following private equity carve outs from larger, parent companies. Kindeva is on an exciting growth journey as a leader and partner of choice in the CDMO business landscape. This journey recognizes the need to make strategic investments and expand our IT team.

Kindeva is seeking a qualified candidate for Senior Project Manager for Manufacturing and Quality Systems that has a passion and the experience to lead key software project initiatives. This role will support multiple production sites in the US and UK and will leverage both project management and manufacturing experience.

Kindeva maintains a modern suite of enterprise applications with numerous exciting expansion opportunities in progress and planned. Over the next 3 years, the business is expected to deploy several, major operational systems like LIMS, ERP Upgrades/Enhancements, MES/EBR, and investments in enterprise reporting analytics and Manufacturing 4.0 strategies to transform our capabilities and deliver improvements to our customers and the patients served.

As a vital member of our Information Technology (IT) team, you will be responsible for overseeing various software related projects; many part of strategic company initiatives. The ideal candidate will possess a strong focus on team leadership, project methodology and best practice, with proven track record of successful projects in the enterprise software space.  The role reports to the IT Director of Manufacturing Systems. 

Domestic travel is expected 1-2 timer per quarter and international travel to the UK will be required at least once annually depending upon on business objectives and project scopes. Relocation will be considered for highly qualified candidates.

RESPONSIBILITIES

• Project Manager role for one of more projects and other related responsibilities within Kindeva’s IT team. Projects typically range in size from 5 to 25 team members and 1 to 6 months in duration.
• Adhere to, and mature, the IT project methodology and tools.
• Drive continuous improvement to all aspects of your role.
• Guide, and support, contract project manager resource time to time. May also coach or mentor internal IT colleagues.
• Ensure projects are managed to ensure compliance with GMP regulations specific to board of health (eg FDA, CBH, MHRA) following a software assurance/GAMP model working closely with the IT Risk Management & Compliance team and Kindeva Quality organization.
• Participate in annual planning/budgeting for key projects and objectives.
• Operate with strong customer focus to ensure both success with projects as well as a service that is highly valued by our internal customers.

WHAT YOU CAN EXPECT FROM KINDEVA

• Strong, patient, and supportive IT Team that is always willing to help and support beneficial business outcomes.
• Plenty of opportunities to learn new IT technologies and processes.
• Flexibility to take on new tasks, new learning and propose new projects or ways of working. We believe in “It’s Your Ship”
• Support for technical and professional skill development.
• A lot of humor and fun conversations with company senior leaders, IT team members, and co-workers.
• Single commitment to customers and patients we serve.

WHAT WE NEED FROM YOU

• Proficient in English.
• Due to statutory requirements and US government products Kindeva manufactures, must be a US Person as defined by the US Department of State.
• 5+ year’s experience managing successful IT projects under a waterfall methodology.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels of the organization.
• One or more of the following certifications will distinguish potential candidates: PMP or CAPM. Scrum, ITIL, or similar also valued.
• Bachelor's degree in Computer Science, Information Systems, or a related field (or equivalent education and work experience).
• Experience working in an FDA/MHRA regulated environment. Experience in a Sarbanes-Oxley, or similar, regulated environment also a plus.
• Proficient with project management tools; MS Project, Smartsheet, or similar tools.
• Expertise in managing software projects including new enterprise implementations upgrades.
• Experience working in a manufacturing environment. Global company experience also a plus.
• Solid understanding of Software Development Life Cycle and best practices.

Kindeva Drug Delivery (KDD)/Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. KDD/MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

California residents should review our Notice for California Employees and Applicants before applying. 
 
Covid-19: