QC Specialist – Cell and Gene Therapy

Galway, Ireland | Permanent full-time role & flexible working conditions

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports cell and gene therapy companies develop, manufacture and supply life-changing therapies to patients.

HiTech Health are seeking to hire a QC specialist for a new cell and gene therapy facility in County Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in quality control testing of starting material, in-process samples and also final product release testing. The QC specialist will play an integral part of the release of clinical/commercial ATMP products.

Responsibilities:

• Test and perform analytical, safety and potency assays for Cell and Gene Therapy products including but not limited to; flow cytometry, cell culture, PCR, DNA gels, western blots and ELISA assays.
• Perform in-process and final product inspections.
• Responsible for authoring QC related Work Instructions, SOPs, client specific validation protocols & validation reports, and other relevant GMP documents.
• Subject matter expert for completion of Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions.
• Complete incoming inspections on raw materials and components in line with controlled procedures and approve raw material inspection records.
• Perform laboratory functions such as daily equipment QC maintenance, inventory management, accessioning samples, data entry, and providing routine administrative support.
• Support process changes from a QC perspective.
• Maintain cleanliness of laboratory preparation areas and equipment.
• Participate in and support HTH equipment qualification programme for QC equipment.
• Prepare, package and label test samples or products for shipping to test sites and other destinations.
• Participate at regulatory authority and customer inspections and meetings as QC representative.

Essential Requirements:

• BSc in Life Sciences.
• Minimum of 3 years technical experience.
• Demonstrative technical experience in flow cytometry, cell culture and PCR assays is essential.
• Knowledge of cell culture-based manufacturing, technology transfer, investigations, and process validation of cell and gene therapies.
• Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
• Enthusiastic and self-motivated.
• Able to manage multiple tasks efficiently.
• Proficient in technical writing and experience in creating; SOPs, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.

Desirable Requirements:

• MSc in a relevant subject area is desirable.
• Experience working with ATMPs.
• Experience in a GMP laboratory.

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 37.5 hrs pw

Start date: To be confirmed – subject to successful candidate’s notice period.

Closing date for receipt of applications is 11th February 2022

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.

Head of Business Development – Cell and Gene Therapy

Ireland | Permanent full-time role & flexible working conditions

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. Operating internationally, HiTech Health supports healthcare companies globally from development to launch and supply of new therapies with a focus on the manufacture, quality assurance and supply of these products.

This is an exciting role for a dynamic and determined individual to join a growing organisation, working as a Head of Business Development (BD) to drive sales in  our Cell and Gene Therapy business. We are seeking for a BD lead to drive our Cell and Gene Therapy CDMO business development, playing a key role in the growth of HiTech Health.

Responsibilities:

• Develop a cGMP cell and gene therapy development and manufacturing customer base.
• Support lead generation activities specifically in cell and gene therapy commercial organisations, research institutions/academic leaders.
• Engage clients at biotech trade events, networking events and becomes active participants in key associations (e.g., BIO, ARM, etc).

• Facilitate site visits for advanced client discussions and/or audit purposes.
• Assist with proposals with technical teams in the overall process for:
  • Proposal generation and communications with prospects
  • Contract negotiation
  • Provide management with reports on Business Development activities
• Deliver and onboard new clients to enable growth of business.
• Lead business discussions with potential clients.
• Establish and maintain contact with decision-makers and influencers within companies.
• Expand HiTech Health’s Cell & Gene Therapy’s brand awareness.
• Maintain relationships with key individuals in the industry and have extensive and up to date knowledge of industry trends and key collaborations and partnerships.
• Set up and manage target territories through the use of the company’s Customer Relationship Management (CRM) tool and provide forecast reporting to management on a routine basis.
• Accountable for meeting/exceeding performance metrics including revenue goals.

Essential Requirements:

• Relevant four-year degree, Masters or PhD in a science/engineering field.
• 5 years experience in biologics or cell and gene therapy CDMO/CMO preferred or extensive experience in highly regulated biotech/biopharma business development/sales organisation.
• Effective communication, interpersonal skills and a positive attitude required.
• Experience with solution selling in a multi stakeholder environment.
• Ability to work collaboratively across the organisation including sales, service, technical support, marketing, and business management functions.
• Must be highly motivated and able to work independently.
• Demonstrate strong entrepreneurial mindset and good negotiating skills.
• Attention to detail in all job functions and demonstrate high level of integrity.
• Anticipate problems and remove obstacles to perform tasks as assigned.
• Work to specific measurable objectives requiring operational planning skills.

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9am-5.30pm daily. The nature of the work may require flexibility in working times.