Job Description

Kindeva Drug Delivery



Kindeva is a global pharmaceutical contract developer and manufacturer (CDMO) business, where we combine life enhancing drugs with state-of-the-art inhalers to provide customers and patients, with top quality respiratory devices.



Our role as a Contract Manufacturer is one, we are incredibly proud of and is one which allows us to be at the forefront of new manufacturing technologies and processes, bringing lifesaving products to patients worldwide.



Due to significant changes in the marketplace Kindeva is currently going through a period of substantial growth and we are looking for talented individuals to join our Loughborough team.

Role Overview:

You will be operating in a pivotal role in the Global Lab Services Organization under the Analytical & Development Services business unit, allowing you to expand your skill set and career prospects by working in a highly regulated sector.

This role is responsible in supporting the creation of and enforce of robust processes for the overall lifecycle for samples as part of testing and projects.

Key Responsibilities include, but are not limited to:

Execute/maintain global sample administration processes for harmonization and transparency of sample life cycle. Including the creation of appropriate SOPs and Work Instructions. Maintain sample chain of custody processes to ensure compliance and efficiency. Support the development of system process to automate sample and project handling. Work closely with Project Managers and Lab Operations to provide visibility to sample disposition. Maintain all sample records as received and stored and shipped. Responsible for the coordination, maintenance, and final disposition of all samples received within Analytical Services and Development. Manage sample activities in accordance with current Regulatory, GMP, business guidelines. Responsible for timely decision-making and resolution of conflicts and raise issues to appropriate management level when needed. Work with EHS to ensure that all samples are received, opened and stored utilizing the appropriate location and PPE. Ensure safe practices that support the shipping of samples and materials to 3rd party vendors, customers and internal sites. Support all inventory and audits/inspections for overall sample management activities. Support KPIs required by leadership team. Continuously improve sample management processes and log lessons learned to share key learning and insights. Provide backup support to Stability Coordination activities, setting up stability studies, pulling samples and completion of workflows and associated documentation. Provide backup support to all shipping and receiving activities required.

Skills & Experience:

Degree in a Science or Engineering based discipline is preferred but not essential. 5+ years of experience in pharmaceutical/medical device or similar industry. Knowledge/experience of pharmaceutical product development, from concept through to product launch. Good Pharma knowledge and experience of pharma product development. Working knowledge and awareness of GMP sample handling. Cross functional team leadership experience. Familiarity with LIMS and LMS.

Key Capabilities:

Computer literate, familiar with Microsoft Word and Excel. Good communication and presentation skills. Good organisational, interpersonal, and time management skills. Enthusiastic, flexible, conscientious and proactive in approach. To work efficiently with supervision or unsupervised as required. Good decision-making and problem-solving skills. Strong verbal and numerical aptitude skills.

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. Flexible working hours. Wellness programmes. Employee recognition program. Employee development. Free on-site parking. Discount and cashback at many retailers. Cycle to work scheme. Flu vaccinations. Employee referral scheme.

Additional information:

Working Hours:

37.5hrs per week

Location:

Charnwood Campus, Loughborough



All applicants must be eligible to work in the UK.



We believe our people make the difference at Kindeva Drug Delivery, looking 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.



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Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees--regardless of format--without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.



Kindeva is an Equal Opportunity Employer