Dr Melinda Scanlen (Phd) Email & Phone Number

South Africa

I’m finally pursuing my passion for scientific writing.

Copenhagen, Capital Region, Denmark

I am a Medical Writer on a freelancing basis as needed. My duties include:• Writing and review of clinical -, literature or research data.• Ensuring that documents are aligned with customer expectations.

Cape Town, Western Cape, South Africa

I manage the production department that includes the tobacco plant platform, the biological platform to cultivate Agrobacterium tumefaciens for expression and the downstream platform that includes protein extraction, purification and formulation and filling. I have five direct reports and a total of 30 staff members in the department. I was appointed in December 2020 with the objective to transform the company from a R&D and development company to full-blown production and to prepare and assist with preparation for ISO 13458 (medical devices guideline) accreditation. I managed to upscale the processes from 1 kg plant batches to 100 kg batches that are purified per week. My duties include:• Setting up the monthly production plan according to sales forecasts.• Managing technology transfers from R&D to Production.• Upscaling of processes and alignment with GMP.• Managing the department’s compliance readiness and implementation of GMP-aligned processes.• Implementation of a production culture.• Upscaling of processes to meet customer demands.

Cape Town, Western Cape, South Africa

Cape Town, Western Cape, South Africa

I was the Production Manager, managing the Production team and deliverables and putting systems in place to comply to ISO13485.

Cape Town Area, South Africa

Due to my expertise and related experience, I was asked to set up and manage a biological API manufacturing facility that complies with all regulatory, quality and company standards. My title changed from API Section Head to API Manager in April 2019 to align with the company’s broadened vision and goals. My duties included:• Oversaw and managed API development, including both upstream (fermentation) and downstream production activities, i.e. purification and conjugation as well as in process testing• Lead robust technology transfers• Ensured adherence to the required hygiene, quality and manufacturing standards, including:­ Met cGMP requirements• Supervised daily production plans and reviewed key metrics• Managed the team’s delivery, specifically ensuring:­ Appropriate SOPs were written and available for the new facility­ Adequate operational training, to ensure delivery against Pharmaceutical Quality System (PQS) requirements­ All due dates were achieved and included detailed corrective and preventive actions (CAPAs), deviations and change controls • Managed API production plan, budget, resources and batch book release

Cape Town, Western Cape, South Africa

Due to a crisis in the Formulation and Filling section, I was seconded to this section for a limited period of time to implement and assess improvements to the existing sectional structure, for commercial readiness in 2020. This was a managerial review of the section to effectively establish sound change management and organisational structures.

Cape Town, South Africa

Responsible for managing the overall Production department, providing effective team leadership, operational efficiency, regulatory compliance, and quality of manufacture. • Managed the performance of the Production department across four manufacturing facilities, specifically:­ Aseptic formulation and filling – Vials­ Aseptic formulation and filling – Pre-Filled Syringes­ Labelling and packing­ Visual inspection (manual and automatic inspection of filled vials and syringes)• Prepared for, and subsequently passed, a regulatory inspection in 2017 for the filling and packing of a new product • Managed a team of about 70 people to achieve manufacturing, project, strategical and budgetary goals• Drove process improvements and effective output monitoring (OEE/OLE and attainment to plan)

Cape Town, Western Cape, South Africa

Responsible for managing the fermentation section/platform in the Product Development department, and evaluating novel process opportunities.• Managed a diverse team, consisting of Senior Scientists, Process engineers, Scientists and support staff • Developed upstream processes and associated testing within the Product Development Department• Managed the documentation deliveries required for each product that was developed• Developed and wrote Chemistry, Manufacturing and Controls (CMC) packages for 3rd parties, one of which was sold and I supported the document transfer and training• Investigated and evaluated business opportunities considering novel biological processes

South Africa

I was acting Division Head for the Biochemistry Division at the Onderstepoort Veterinary Institute (OVI) from September 2001 until April 2002 and again from August 2002 to November 2003 when I resigned to join the Biovac Institute.Scientific role: Development of a prototype recombinant subunit vaccine for AHSV-5.

South Africa

South Africa

Phd, Virology And Immunology

Msc (Agric), Molecular Biology And Virology

Bsc (Agric)(Hons), Microbiology

Bsc (Agric), Microbiology