Project Manager

Kindeva-Drug-Delivery-Careers; Clitheroe; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Company pension

Holiday allowance

Medical Insurance

Life cover

Employee assistance

Job summary

Kindeva is seeking a seasoned Project Manager to lead development of manufacturing processes within pharmaceutical operations and manage cross-functional teams from development to commercialization.

You will oversee schedules, budgets, risk management, and CAPEX, ensuring GMP and ISO9001 alignment across internal sites and external partners.

Strong communication and mentoring skills are essential to drive projects successfully in a fast-paced environment.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 3+ years’ experience in a technical role within pharmaceutical operations/product development/process development.
• 4+ years’ experience with project management.
• Experience working within ISO9001.
• Proven track record of detailed program management and thorough communication.
• Ability to lead integrated process teams and coordinate project requirements.

Responsibilities

• Lead development of project charters and initial requirements.
• Scope project requirements for NPI, product line extensions, technical transfers and optimization.
• Ensure design, system performance, quality and COGs compliance with engineering teams.
• Maintain compliance with Health, Safety, Environmental and GMP requirements.
• Mentor employees to develop project management capabilities and coach teams.

Skills

Project management

Pharma operations

Process development

ISO9001 experience

Education

Bachelor's Degree in Engineering

Job description

The Impact You Will Make:

You will be responsible for maintaining schedules, budgets and Cost of Goods (COGs) as they relate to the technical development of Manufacturing Processes in Kindeva commercial sites, and at our Outsource Partners.

In this role you will possess both technical expertise in the development of manufacturing processes, and the proven experience in the cross-functional coordination of technical professionals.

Key Responsibilities include, but are not limited to:

• Lead development of Project Charter, document the initial requirements that satisfy the stakeholder’s needs and expectations
• Scope project requirements in support of new product introduction, product line extension projects, technical transfers and product optimization projects.
• Work with the engineering team to ensure specification/requirement compliance in the areas of: design, system performance, quality, and COGs.
• Ensure all projects are executed within Health, Safety, Environmental and GMP requirements.
• Resourceful and action-oriented to remove barriers to success and achieve results despite occasional limited resources or challenging work environment.
• Participate in phase gate reviews internally, with external partners, and customers.
• Strong verbal and written communication to include technical communication skills to accurately convey technical issues and information.
• Projection of unit costs and CAPEX spend to get from development to commercialization.
• Demonstrate an expert understanding of functional project frameworks and project management concepts, techniques, tools, and best practices.
• Creation, management and communication of detailed project plans with foresight to elevate constraints.
• Develop complex aspects of a project related to a specific function.
• Mentor employees in developing project management capabilities.
• Manage high level strategic projects that affect the entire organization.
• Ensure a relevant risk management and contingency plan is in place for each project.
• Lead introduction of new products, processes, and technologies within operations.
• Apply technical product and process knowledge to the development of project plans.
• Represent Operations on Development project teams to ensure technical feasibility and alignment with commercial capabilities.
• Provide technical process input to NPI early-stage and new business proposals.
• Work closely with Development and Engineering functions to ensure smooth transition of products, equipment and processes into commercial operations.
• Based on product/process knowledge, anticipate technical hurdles and identify mitigation strategies.
• Establish metrics to aid in decision making, for self and teams.
• Demonstrate knowledge of the organization's risk and opportunities within the market.
• Influence, support, and communicate the strategic direction of the organization.
• Demonstrate expert insight into the organization's risks and opportunities within the market.
• Adeptly and appropriately leverage influence to achieve business unit outcomes.

Skills & Experience:

• Bachelor’s Degree in Engineering, Science or related technical field.
• 3+ years’ experience in a technical role within pharmaceutical operations/product development/process development.
• 4+ years’ experience with project management.
• Experience working within ISO9001.
• Requires track record of detailed program management exhibiting comprehensive planning and thorough communication.
• Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating project requirements.

Key Capabilities:

• Excellent interpersonal and communication skills, both written & oral at all levels.
• Able to work both as part of a cross-functional team but also act independently.
• Proficient in leading teams, as well as coordinating and communicating project requirements.
• Comfortable working with detailed technical information but also able to see the overall business picture.
• Demonstrate an expert understanding of functional project frameworks and project management concepts, techniques, tools, and best practices.
• Demonstrate flexibility, strategic thinking and drive to succeed.
• Able to deliver results accurately within demanding time frames.
• Adapt to changing priorities, timelines, and expectations without compromising on quality.
• Maintain a high standard of accuracy, completeness, and documentation.
• Champion data integrity and a right first-time culture.

What we Offer:

• Attractive compensation package.
• Company pension scheme (up to 10% employer contribution).
• 25 days holiday per year (plus bank holidays) plus service days after 5 years.
• Private Medical Insurance.
• Company sick pay.
• Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family.
• Life assurance of four times life cover salary.
• Wellness programmes.
• Employee recognition program.
• Free on-site parking.
• Discount and cashback at many retailers.
• Cycle to work scheme.

Additional Information:

Location: Up Brooks, Clitheroe – update location as appropriate

All applicants must be eligible to work in the UK.

We believe our people make the difference at Kindeva, we look for skilled, passionate, and driven professionals to come and work with us to help us excel in manufacturing technologies and processes, which bring lifesaving products to patients worldwide.

Kindeva is an Equal Opportunity Employer