Senior Quality Director (ICH-GCP) – San Francisco, CA This is an opportunity to work with one of the Biotechnology companies in the Bay Area, CA, and they are actively seeking talented and experienced individuals to join their business as a Senior Quality Director with a focus on GCP.   Responsibilities ·        Responsible for development of Quality GCP strategy for largest Therapeutic Area within the business (ICH-GCP, ICH Q9, ICHE6 R3) ·        Spearhead creation of Audit Management Strategy as well as hosting Internal / External Audits ·        Responsible for hiring, developing & leading GCP Quality team ·        Support Management & Testing of API and DS activities (cGMP) ·        Cross-functional collaboration with other Quality teams, Regulatory, Clinical & more   Requirements ·        10+ Years’ of GCP Quality experience in the Pharmaceutical  and/or Biotechnology space ·        Experience creating & implementing Risk & Audit Management Programs ·        People leadership experience required ·        Minimum Bachelor’s degree in a Life Sciences or equivalent field   If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to J.Greavesjohnson@sciproglobal.com.

SciPro are partnered with a leading healthcare company on their search for a Contract QP with a focus on leadership and support to Quality Managers across the business Role Tasks: Undertake Qualified Person (QP) responsibilities as defined in Annex 16 of the MHRA Orange Guide.Perform the duties of 'Responsible Person' as detailed in the 'Rules and Guidance for Pharmaceutical Distributors' - MHRA Green Guide.Named responsible person on MIAH and MIA(IMP) licences held by group sites in accordance with the requirements of EU GMP.Liaise directly with the regulatory authorities on behalf of the company, to seek clarification or guidance where it is considered appropriate.Management of the downstream Quality Management processes performed across the various sites such as internal/external audits, change control, non-conformances, CAPA, validation.Responsible to Senior Management for the performance of the QMS.Proactively identify improvements to the QMS through the preparation of various trending reports for Management Review.Effectively create and support an environment of continuous improvement throughout the organisation by the identification of process improvement opportunities within the controls and practices of the Quality Management System and oversee the implementation of such improvements. These improvements should streamline or enhance existing operational processes rather than simply add further requirements.To promote a culture of Quality excellence, driving cultural change within the entire business towards the goal of developing Quality Management System(s) appropriate to all areas of the business.Responsible for the Group's Quality Compliance to ensure compliance with the relevant regulatory agencies and all applicable standards. Skills / Knowledge /Experience:Significant experience gained from working in a Pharmaceutical environment. Have the required experience to effectively perform the expected duties in roles as both QP & RPMany years in various management roles within QA.Successful multi-disciplinary projects to deliver business benefit and/or QMS enhancementsExcellent interpersonal skills with the ability to work with and influence senior members of staff to ensure robust and reliable systems are in place.Successful preparation and involvement with regulatory inspections/audits including MHRA and Medical Device Notified Bodies.Meet the requirements of continuing professional development required to maintain QP status. Minimum of a B.Sc. degree in a scientific, health care or related discipline and/or background in a medical health profession.

Senior Scientist – San Francisco, CA This is an opportunity to work with a early clinical-stage Biotech company out of San Francisco, CA, and they are actively seeking talented and experienced individuals to join their business as a Senior Scientist.   Responsibilities ·        Responsible for developing chemical compounds including Lipids, polymers & more ·        Discovery & Formulation, as well as Process Development of Lipid Nanoparticles for mRNA &other modalities ·        Responsible for training & development of new members of the business ·        Work alongside external CDMOs   Requirements ·        PhD Educated in Chemistry or similar ·        Extensive experience in development of Lipid Nanoparticles for Drug Delivery ·        Analytical Method experience (HPLC, TLC & more) ·        Project Lead experience and ability to coach & develop others   If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to J.Greavesjohnson@sciproglobal.com.

Senior Quality Associate – Carlsbad, CA This is an opportunity to work with one of the fastest growing Biotechs in Southern California, and the are actively seeking talented and experienced individuals to join their business as a Senior Quality Associate.   Responsibilities ·        Responsible for Lot Disposition activities for all Drug Substance (DS), Drug Product (DP) and final packaged Clinical product ·        Support all Clinical Trial Packaging and Labelling Activities ·        Responsible for Quality training & development of new members of the business ·        Support Management & Testing of API and DS activities (cGMP) ·        Support Commercial Quality Control activities for future commercial products   Requirements ·        Min. Bachelor’s degree in Life Sciences discipline ·        3+ Years’ of experience in Quality Assurance in the Pharmaceutical and/or Biotechnology space ·        Experience in a large-scale Manufacturing cGMP environment ·        Knowledge and experience in Packaging & Labelling of products throughout Clinical Trials ·        Knowledge of both Drug Substance & Drug Products processes   If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to J.Greavesjohnson@sciproglobal.com.

Senior Automation Engineer This is an opportunity to work the most successful cGMP certified CDMOs on the West Coast right now. They are actively seeking a senior level expert in Automation Engineering to manage Automation processes in a Regulated Pharmaceutical environment. Responsibilities • Streamline & Automate Manufacturing Processes using technology created by their central headquarters • Spearhead the Design & Instalation of all Automation systems (Including but not limited to HVAC, Waste Water Systems & Lyophilizers) • Fully understand Automation Processes & Provide Consultation to team members Requirements • 8+ Years’ of Automation Engineering experience in a Pharmaceutical Environment (cGMP) • Platform Experience including WinCC, FactoryTalk, Ignition & others • Minimum Bachelor’s Degree in Engineering or Similar If this is a role that interests you then please click respond through the LinkedIn apply function or send your resume over to J.Greavesjohnson@sciproglobal.com.