Olga Mollin Email & Phone Number

Watertown, Massachusetts, Us

Cambridge, Massachusetts, Us

Accountable for end-to-end manufacturing and supply to support commercial launch of AFX3772 MAPS™ vaccine program for Streptococcus pneumoniae and subsequent vaccine pipeline. The role included external and internal manufacturing for drug substance, drug product and intermediates, facility management, supply chain management, outsourcing strategy, manufacturing capacity planning and capital project execution to maintain uninterrupted product supply. Affinivax was acquired by GSK in August 2022, whereupon the role was integrated into the GSK global organization.

Paris, France, Fr

Member of the Specialty Care External Supply Leadership Team operating as a global virtual multi-product manufacturing site with a focus on biologics within Sanofi's Industrial Affairs Division. The team is accountable for e2e product supply to market for commercial products (25% of total Sanofi product portfolio produced at CMO), supply readiness for product launch and regulatory market management. Current portfolio includes approximately 20 products (commercial/ clinical/pipeline), working with 25 CMOs through 40+ contracts. Key Achievements:✔ Collaboration with strategic planning, sourcing, procurement, and licensing to develop the external supply network in accordance with Sanofi's manufacturing strategy. Oversight of contract, relationship, delivery and business performance of key external contract organizations. ✔ Relationship management activities and development of new business growth opportunities with existing partners✔ New Product Introduction Leader for tech transfer to CMO to add capacity for supply of product. Member of sourcing and negotiation team which secured contract and budget approval within 5 months from sourcing decision. Coordinated stakeholder/SME inputs to establish a project plan to operationalize the contract and outline deliverables from tech transfer kick off to US FDA approval. Further improved project timeline from kick-off to submission by 10%, whilst delivering CAPEX project implementation within budget, GMP Engineering run for use as clinical material 10 months after kick-off and right first time DS PPQ batches. Team member for regulatory strategy Type C request to FDA.

Waltham, Ma, Us

Bioverativ representative as the Virtual Plant Manager for a Biologics Drug Substance Contract Manufacturing Organization (CMO). Owner of the supply relationship ensuring CMO performance in alignment with strategic goals. Leads the manufacturing program as the primary interface with the CMO and drives all contract and program management including technical transfers, new product introductions, compliance initiatives and continuous improvement projects in collaboration with Technical Development, Regulatory, Legal, Quality, Logistics, Planning and Program Management. Management of all financials associated with the relationship including operating expenses. Negotiation of contract terms.

Basel, Ch

Led two production lines with full P&L responsibility for 60% of site batch production. Direct responsibility for the Manufacturing team (170 employees), leader for the cross functional matrix organization, including Engineering, EHS, PM, QA, MSAT, QC, PPL, OE, Training. As Program Sponsor for 6 products oversaw Lonza/Customer project teams and served on Business Review Teams / Joint Steering Committee. Served as an integral member of the Site Leadership Team (SLT) accountable for overall site performance.Key Achievements in 2017:✔ Delivered 11% increase in GP and exceeded Asset P&L target by $1M.✔ Attained 100% On Time In Full (OTIF) product delivery for 1 critical product line.✔ Achieved 99% Capacity Utilization, <1% financial variances for cost center budget.✔ Identified opportunities and delivered approximately $500K savings related to deviation investigation management. ✔ Represented Portsmouth site operations on cross functional global team evaluating future manufacturing strategy and plans.

Basel, Ch

Developed contract price agreements, work scope, scheduling, forecasting and management of contract deliverables for a range of services including process development, technology transfer to manufacturing scale, analytical and process validation and associated regulatory support for completion of product commercialization. Managed 8 products, 6 customers. Key Achievements:✔ Secured additional contracts with existing clients totaling approximately $20M. ✔ Established contract template for data services to standardize offering and ensure implementation at phase appropriate time.

Basel, Ch

Managed all operational aspects for upstream manufacturing. Spearheaded the restructure of manufacturing cell culture and purification areas in collaboration with downstream counterpart. Integral member of Quality Systems Oversight (Deviation Review Board, Change Control Committee, Material Review Board, Vendor Change Notification). Manufacturing reviewer of applicable CMC filing sections. Review and input to client RFP. Key Achievements:✔ Doubled number of batches produced per year. ✔ Reduced voluntary attrition rate from 11 to 6% in readiness for business growth and expansion of department from 95-125 staff.✔ Implemented a Pilot Program for Leadership Effectiveness in 2012 that was incorporated into annual performance reviews for the site.✔ Led Site Safety Hoshin Strategic Projects in 2010 and 2011 that ensured adherence to Safety, Health, and Environmental initiatives and requirements.

Basel, Ch

Responsible for 3 x 5,000L and 2 x 1,500L commercial cell culture suites, management of 4 direct and approximately 60 indirect reports. In parallel with production, undertook 10 process technology transfers for new customer products into the Portsmouth facility and 2 detailed facility fit customer product evaluations for new suites. Identified as contamination investigation expert in Lonza global mammalian network providing onsite evaluation at three locations to help reach a successful production re-start. Delivered presentations during FDA, EMEA, Canadian, Mexican, Japanese, Brazilian, Turkish regulatory inspections and frequent customer audits.

Basel, Ch

Basel, Ch

Bachelor’S Degree, Biotechnology

Master Of Business Administration (M.B.A.)