Process Transfer Manager - Medical Devices 13485 in Manchester, Greater Manchester, United Kingdom

Our Client is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, and to aid in biomedical research. They are also a leader in development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women.

JOB SUMMARY

  • Responsible for the support of launched/approved products and operations processes and the creation and transfer of manufacturing processes from R&D to Manufacturing and site to site transfers of on-market products.
  • Responsible for the development of LEAN processes by the removal of waste and continuous improvement of existing process.
  • Responsible for the development of new processes, transfer to manufacturing and continuous improvement of existing processes.
  • Provide process support to Manufacturing and other Operations Groups.
  • Responsible for Pilot & Development Manufacturing activities, Scale-Up of production processes as the production demand dictates.
  • Provides the support needed to complete Process Validation activities and training of manufacturing staff during the validation cycle.
  • Directs Subordinates to complete assignments using established guidelines, procedures and policies. Monitors daily operations of the Process Transfer Department.

ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Ensures team actions and deliverables are completed to the required due dates and project timelines.
  • Works collaboratively to problem solve with other departments.
  • Performs document review and approvals for the department.
  • Operates effective performance management of the Process Transfer team setting appropriate and business aligned goals, reviewing against expectations.
  • Provides guidance and development opportunities for team members.
  • Develops validation strategies for projects and agrees with the responsible member of Quality Engineering.
  • Contributes to department budget creation and ensures that department expenditure is within or below expectations.
  • Assigns and determines the team workload and priorities.
  • Oversees the development inventory locations and development production activities
  • Produces notebook, development, pilot and production materials
  • Oversees ERP real time transactions.
  • Reviews and independently generates notebook studies, technical reports, development and manufacturing documents.
  • Oversees and executes process validation of new and existing manufacturing processes
  • Represents Process Transfer on one or more core teams.
  • Provides the main point of contact and participates on behalf of Process Transfer in FDA and ISO lab audits.
  • Assists with troubleshooting experimentation required for projects.
  • Troubleshoots complex manufacturing process problems.
  • Oversees the development of manufacturing processes for transfer to Manufacturing.
  • Trains Manufacturing Operators on newly developed procedures.
  • Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
  • Reports periodically to management on project progress and status.
  • Provides technical support to Operations groups
  • Responsible for the Engagement plan and execution for the Process Transfer team.
  • Drive Value Improvement Project initiative for the team.

REQUIRED SKILLS

  • Typically requires BA or BS and experience desired
  • Working knowledge of experimental design.
  • Advanced knowledge of current GMPs.
  • Blood Borne Pathogen training.
  • Interpersonal skills
  • Technical skills
  • Work under own initiative and uses own judgment
  • Works collaboratively
  • Builds working relationships
  • Problem Solving
  • Proficiency with MS Word and Excel.
  • Strong math skills.
  • Applied knowledge of Technical writing.
  • Experience with presentation skills.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k

JOB SEARCH

Keywords / job title / skill

Type any location in the box above, or select below :
Africa
Asia & Pacific
CIS
Europe
Middle East
North America
South America
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas, The
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
British Virgin Islands
Brunei
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo, Democratic Republic of the
Congo, Republic of the
Cook Islands
Costa Rica
Cote d'Ivoire
Croatia
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
East Timor
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands (Islas Malvinas)
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern and Antarctic Lands
Gabon
Gambia, The
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, South
Kosovo
Kuwait
Kyrgyzstan
Laos
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab
Liechtenstein
Lithuania
Luxembourg
Macau
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova, Republic of
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian territories
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn Islands
Poland
Portugal
Puerto Rico
Qatar
Reunion
Romania
Russia
Rwanda
Saint Barthélemy
Saint Helena
Saint Kitts and Nevis
Saint Lucia
Saint Martin
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the Islands
South Sudan
Spain
Sri Lanka
Suriname
Svalbard
Swaziland
Sweden
Switzerland
Taiwan
Tajikistan
Tanzania, United Republic of
Thailand
The Former Yugoslav Republic of Macedonia
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
United Arab Emirates
United Kingdom
United States
United States Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
Virgin Islands (US)
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe

Country, town, city or postcode

--Web2New--